About Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Unit Clinician RN (PRN) assists with the conduct of clinical trials through dispensing investigational drugs, the collection of biological samples, performing venipuncture, electrocardiograms, tube labeling, sample processing, documenting in subject charts, and other related tasks in accordance with the doctor’s written orders. In executing these responsibilities, the Unit Clinician is guided by Good Clinical Practices (GCP).
Responsibilities:
Dispense and collect investigational products, routine medications, and PRN medications while subjects are housed on the site observation unit as dictated by written orders.Perform appropriate research protocol procedures which may include but are not limited to vital signs, blood collection and processing, ECGs, and point of care laboratory tests.Perform basic lab procedures including but not limited to preparation of specimen tubes and labels, blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-ups.Ensure that biological specimens are disposed of appropriately.Maintain a clean, safe work environment.Study, learn and comply with ERG site standard operating procedures, and other policies, practices, and regulations where applicable.Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.
Skills and Qualifications:
Education and experienceGraduate / completion of approved accredited school of nursing. Education and requirements will be determined by the site’s need and protocol requirements.Valid License as an RN in the state of Texas; maintain current license.Must have a minimum of one (1) year of clinical experience.BLS/CPR Certification required, ACLS preferred for LPN.Phlebotomy certification (national) preferred.Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.Communicate with providers, co-workers, and others in a collaborative and courteous manner.Knowledgeable in medical terminology to communicate with physician office and staff.RequirementsAbility to work independently and as a team player.Ability to organize and prioritize within a changing environment.Uses safety/universal precautions to protect self, subjects and staff.Able to appropriately implement protocol and regulatory requirements in study conduct.Proficient in venipuncture, centrifugation, sample storage and performing electrocardiogram.Excellent documentation practicesGood organizational and interpersonal skillsAttentive to detail, good initiative and able to work with changing priorities.About Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Laboratory Medical Technologist is responsible for performing laboratory testing and specimen processing in support of clinical research studies. This position ensures accurate and timely analysis of biological specimens while maintaining compliance with study protocols, Good Clinical Practice (GCP), Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and applicable regulatory standards. The Medical Technologist works closely with clinical research coordinators, investigators, sponsors, and laboratory personnel to ensure the integrity of laboratory data and the successful execution of clinical trials.
Responsibilities:
Perform laboratory testing on blood, urine, tissue, and other biological specimens according to study protocols and laboratory standard operating procedures (SOPs).Collect, process, centrifuge, aliquot, label, package, and store research specimens according to protocol requirements.Maintain specimen chain of custody and ensure proper documentation throughout the testing process.Operate, calibrate, troubleshoot, and maintain laboratory instrumentation and equipment.Perform routine quality control, proficiency testing, and quality assurance activities.Review laboratory results for accuracy and identify discrepancies or abnormal findings requiring further investigation.Ensure all laboratory activities comply with CLIA, CAP, OSHA, HIPAA, Good Clinical Practice (GCP), and institutional policies.Prepare specimens for shipment to central laboratories while adhering to applicable shipping regulations.Maintain laboratory inventory, including reagents, supplies, and consumables.Document laboratory procedures, deviations, maintenance records, and quality control activities accurately and completely.Assist with laboratory audits, sponsor monitoring visits, and regulatory inspections.Collaborate with clinical research staff to ensure laboratory requirements are met for study enrollment, participant visits, and protocol compliance.Participate in the development and revision of laboratory SOPs and training materials.Maintain a clean, organized, and safe laboratory environment.Participate in continuing education and competency assessments.Skills and Qualifications:
Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Biology, or a related scientific field.Certification as a Medical Laboratory Scientist (MLS), Medical Technologist (MT), or equivalent through a nationally recognized certifying agency (ASCP, AMT, or equivalent).Minimum of 2 years of clinical laboratory experience; research laboratory experience preferred.Knowledge of laboratory quality systems, specimen handling, and laboratory safety practices.Strong analytical, organizational, and problem-solving skills.Excellent written and verbal communication skills.Proficiency with laboratory information systems (LIS) and Microsoft Office applications. Read LessAbout Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Lab Assistant will perform basic and complex clinical and pharmacokinetic specimen collection and processing (upon assignment) for Phase 1 clinical trials, primarily healthy paid volunteers. Duties will primarily focus on assisting the Lab Manager in processing laboratory samples but will also include clerical and data entry duties. Hours are project dependent and sometimes require weekends and/or very early or late hours.
Responsibilities:
Monitor urine collection temperatures, as assigned.Monitor 24-hour specimen collections (i.e., urine, feces), as assigned.Maintain sample collection area clean and stocked with all necessary supplies.Notify appropriate staff of abnormal results while collecting specimens, adverse events, or unusual incidents.Act as courier to Pharmacokinetic laboratory for collected specimens.Assure minimal discomfort for study participants while performing all duties.Maintain safety and well-being of study participants during assigned shift.Safety lab requisition creation and sample send out to the local labs.Labeling of PK/PD collection tubesAdditionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.Skills and Qualifications:
Certification as a Phlebotomy Technician and/or a minimum of six months experience working as a phlebotomist at a medical facility.Clinical Research experience preferred but not required.BLS and/or ACLS certification preferred but not required.Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.Knowledgeable in medical terminologyExcellent communication skills (interpersonal, written, verbal)Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)About Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Pharmacist prepares, compounds, manufactures, and dispenses investigational drugs and materials issued by the company for ongoing research studies. In executing these position responsibilities, the Research Pharmacist is guided by Good Clinical Practices (GCP), International Committee on Harmonization (IHP) guidelines, and company standard operating procedures and policies.
Responsibilities:
General
Perform all study activities under the direction and delegation of the Principal Investigator Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator prior to the effective date of the study. Assist in establishing and maintaining a collaborative relationship with the Principal Investigator and the pharmacy. Meet with the investigators, study monitors, and others in coordinating study logistics.Receive copies of investigational brochures, study protocols, and pharmacy binders. Reviews documents and determines pharmaceutical materials and professional services required to satisfy the study description.Pharmacy Activities
Develop step-by-step procedures and/or kit for preparation, dispensing and distribution of investigational and study drug. Develop codes, labels and other predefined formats for pharmacy computer entry. Establish and maintain adequate and easily retrievable recordkeeping systems for protocols, study subjects, drug inventory and dispensing investigational drugs per regulatory requirements and ICH guidance requirements for handling investigational products Responsible for the development of staff training regarding investigational and study drug procedures. Trains Research Pharmacy Technician, clinical research coordinators or any other appropriately delegated staff in the preparation of these agents, labeling appropriate record keeping and dispensing and kit utilization Prepare drug data sheets and other documents for Research Pharmacy Technician. Establish and maintain standards which assure the quality, proper storage and safe use of all investigational agents and related supplies. Delegate the ordering and stocking of investigational and study agents to the Research Pharmacy Technician(s). Ensure that this work is done according to protocol guidelines. Delegate the removal and disposal of expired stock or stock from completed or terminated studies to the Research Pharmacy Technician. Ensure that this work is done according to protocol guidelines. Ensure that paperwork is completed and retained, and that investigational and study drugs are handled according to the requirements of the sponsoring agencies. Prepares special formulations of investigational agents under unusual circumstances as dictated by a particular protocol. Responsible for and assist with the development of statistical reports and activity summaries as appropriate monthly. Such reports will be submitted to the Medical Director, Site Director, and Senior Clinical Research Coordinator for review. Responsible for and assist with appropriate monthly pharmacy audits to ensure that company policies and procedures are met. Assist in quality assurance procedures as needed. Maintain a neat and clean work area. Develop well organized work routine Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.Skills and Qualifications:
Education and experienceA PharmD or a bachelor's degree in pharmacy from an accredited school of pharmacy and one year of pharmacist experience. Current licensure as a pharmacist in the state of hire Prior hospital pharmacy experience strongly preferred. Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines. Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in medical terminology to communicate with physician office and laboratory staff. Demonstrate the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy. Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change. RequirementsExcellent communication skills (interpersonal, written, verbal) Ability to perform overnight business travel Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)About Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Laboratory Technician is responsible for assisting with document management, protocol related clinical assessments of research subjects, laboratory functions, and assisting in tasks of the Clinical Research Coordinators as it relates to the conduct of clinical trials. Completes all duties under the direction of the Site Director or designee. Maintains accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Intake Assistant is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies.
Responsibilities:
Maintain tenants of good customer service when interacting with subjects, staff, and representatives of sponsors or CROs. Clinical skills include phlebotomy, vital sign measurements, and performing ECGs.Collect demographic, medical, and medication history. Complete safety assessments Work closely and collaboratively with Director of Clinical Operations, Clinical Research Coordinators, Sub-Investigator, and Principal Investigator. Enter data as appropriate for multiple Electronic Data Capture platforms as well as respond and resolve queries that may arise.Meet defined goals established in conjunction with site leadership. Study, learn, and comply with ERG site standard operating procedures, and other policies, practices, and regulations where applicable. Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.Skills and Qualifications:
Education and experienceHigh School Diploma or equivalentExperience in a medical setting/ training and certification as a Medical Assistant/CNARequirementsUnderstands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines. Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.Good organizational and interpersonal skills Attention to detail. Knowledgeable in medical terminology Excellent communication skills (interpersonal, written, verbal) Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)About Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Unit Clinician assists with the conduct of clinical trials through dispensing investigational drugs, the collection of biological samples, performing venipuncture, electrocardiograms, tube labeling, sample processing, documenting in subject charts, and other related tasks in accordance with the doctor’s written orders. In executing these responsibilities, the Unit Clinician is guided by Good Clinical Practices (GCP).
Responsibilities:
Dispense and collect investigational products, routine medications, and PRN medications while subjects are housed on the site observation unit as dictated by written orders.Perform appropriate research protocol procedures which may include but are not limited to vital signs, blood collection and processing, ECGs, and point of care laboratory tests.Perform basic lab procedures including but not limited to preparation of specimen tubes and labels, blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-ups.Ensure that biological specimens are disposed of appropriately.Maintain a clean, safe work environment.Study, learn and comply with ERG site standard operating procedures, and other policies, practices, and regulations where applicable.Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.
Skills and Qualifications:
Education and experienceGraduate / completion of approved accredited school of nursing. Education and requirements will be determined by the site’s need and protocol requirements.Valid License as an LPN in the state of practice; maintain current license.Must have a minimum of one (1) year of clinical experience.CPR Certification required, ACLS preferred for LPN.Phlebotomy certification (national) preferred.Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.Communicate with providers, co-workers, and others in a collaborative and courteous manner.Knowledgeable in medical terminology to communicate with physician office and staff.RequirementsAbility to work independently and as a team player.Ability to organize and prioritize within a changing environment.Uses safety/universal precautions to protect self, subjects and staff.Able to appropriately implement protocol and regulatory requirements in study conduct.Proficient in venipuncture, centrifugation, sample storage and performing electrocardiogram.Excellent documentation practicesGood organizational and interpersonal skillsAttentive to detail, good initiative and able to work with changing priorities.About Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Lab Assistant will perform basic and complex clinical and pharmacokinetic specimen collection and processing (upon assignment) for Phase 1 clinical trials, primarily healthy paid volunteers. Duties will primarily focus on assisting the Lab Manager in processing laboratory samples but will also include clerical and data entry duties. Hours are project dependent and sometimes require weekends and/or very early or late hours.
Responsibilities:
Monitor urine collection temperatures, as assigned.Monitor 24-hour specimen collections (i.e., urine, feces), as assigned.Maintain sample collection area clean and stocked with all necessary supplies.Notify appropriate staff of abnormal results while collecting specimens, adverse events, or unusual incidents.Act as courier to Pharmacokinetic laboratory for collected specimens.Assure minimal discomfort for study participants while performing all duties.Maintain safety and well-being of study participants during assigned shift.Safety lab requisition creation and sample send out to the local labs.Labeling of PK/PD collection tubesAdditionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.Skills and Qualifications:
Certification as a Phlebotomy Technician and/or a minimum of six months experience working as a phlebotomist at a medical facility.Clinical Research experience preferred but not required.BLS and/or ACLS certification preferred but not required.Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.Knowledgeable in medical terminologyExcellent communication skills (interpersonal, written, verbal)Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)Location: This role is onsite at CPMI in Miami, FL
If you are not local to Miami, let's discuss how to get you there!
This is a newly created role at an amazing, top clinical research site located in Miami, FL
About Company:
Who is ERG?
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.
About the Role:
We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs. Core duties include staff management, protocol review, quality assurance, and overall study supervision.
Responsibilities:
Lead and mentor the clinical operations team to promote a collaborative and efficient environment.Ensure protocol compliance and maintain high-quality standards across studies.Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies.Oversee human resources functions, including staff evaluations, recruitment, and training.Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies.Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators.Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation.Conduct study closeout procedures.Perform additional duties as needed to adapt to the evolving needs of CPMI.Ensure compliance with all applicable regulations and guidelines, including FDA, ICH, and GCPMinimum Qualifications:
Bachelor's degree in a scientific or healthcare-related field7-10 years of experience in clinical operations, including 5+ years in a senior leadership role.Strong understanding of FDA, ICH, and GCP regulations and guidelinesStrong communication, organizational, and leadership skills.Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software.In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-outExperience managing and mentoring a team of clinical operations professionalsPreferred Qualifications:
Phase I or early phase experienceBi-lingual in English and SpanishBenefits Overview:
Our comprehensive benefits package includes:
Health insuranceDental & Vision InsuranceMatching 401k Retirement PlanPaid Time Off (PTO) Read LessAbout Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Study Manager (SM) is responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s). The SM, in concert with the Senior Clinical Team Lead and Principal Investigator, is accountable for achieving successful conduct of the project at the site level by meeting Sponsor on time, with the highest quality.
This position will have a variable work schedule, including flexible hours and occasional weekends.
Responsibilities:
Primary site contact for assigned clinical studies.Lead site clinical team in sponsor study startup and study conduct.Ensure effective study plans are in place and operational for each trial and work proactively with the Clinical Trial Team to set priorities in accordance with applicable study plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.Proactively manage site level operational aspects of their assigned clinical study and ensure the timely delivery of all requested study logs/spreadsheets to sponsors i.e., Enrollment logs, protocol deviation spreadsheet, AE spreadsheet etc.Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.Ensure the quality of vendor deliverables, address quality issues with the appropriate team member/s and identify opportunities to improve training, execution, and quality control across the clinical team.Ensure all site level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.Skills and Qualifications:
Minimum of 2 years of experience in clinical research coordination and project managementManaging project teams through excellent interpersonal communication skills; experience motivating a group to reach a common goal and working collaboratively.Planning and organizational skills are required.Must have a thorough knowledge of clinical research concepts, practices, FDA regulations and ICH.Guidelines regarding drug development phases, clinical research, and data management methods.Excellent verbal and written communication skillsAbout Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
The Laboratory Director supervises the laboratory assistants to ensure provision of quality specimen processing, archiving, shipping, and effective team performance to meet site goals.
Responsibilities:
Supervise laboratory assistants to ensure all study specimens are processed and archived according to protocol specifications.Notify the appropriate management staff of missed time-points, insufficient sample collection, improper specimen collection or unusual incidents.Oversee and/or prepare the collection tubes, vials, containers, etc. with study and subject identification labels for protocol specific collection time-points.Assist in maintaining the specimen processing area is clean, set up according to protocol requirements and that all required supplies are stocked.Perform duties of processing, archiving and/or shipping specimens Assist in a variety of routine blood drawing procedures to include venipuncture techniques using standard equipment to include vacutainer tubes and sleeves, tourniquets, syringes, and butterfly needles, as assigned.Ensure appropriate tubes, vials and containers necessary for specimen collection are used, depending upon tests ordered.Must be able to provide top quality care and concurrently handle high levels of stress.Clinical skills indicated by level of education, licensure, registration and/or certification.Perform study specimen collections and collects clinical data as directed by principal investigator and protocol.Serve in rotation as on-call supervisor.Facilitate the team process including interdisciplinary communications.Participate in collaborative team efforts with other departments.Ensure that processing laboratory areas are properly stocked with study supplies (i.e., blood tubes, vials, kits, containers, study flowsheets, etc.)Ensure PK Laboratory is properly staffed for processing, archiving, and shipping requirements by reviewing study schedules for each specific protocol.Ensure accurate maintenance of records with regards to the research projectAssist in giving accurate and easily accessible research data to the Data Entry department.Anticipate, recognize, and resolve issues.Recognize the need to seek assistance or inform senior management of specific issues.Lead necessary team training efforts for all facets of the Pharmacokinetic Laboratory Read and understand each protocol in which she/he is involved.Keep appraised of the current implementation of OSHA, FDA and GCP/ICH regulations, guidelines, and procedure.Follow established guidelines in the collection of clinical data and/or administration of clinical studies.Comply with all site policies and procedures, especially those regarding protocol confidentiality.Demonstrate a caring, professional attitude and behavior toward study participants and staff, actively contributing to the well-being and dignity of the clinic.Maintain an overall good work attitude, promoting cooperation and professionalism and interactions with other staff members.Maintain assigned work areas in a clean, safe condition, and report any potential hazards immediately.Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.Skills and Qualifications:
Education and experienceA minimum of a High School diploma with 5 years of specimen processing and collection experience OR professional licensure, registration and/or certification in a clinical or allied health field is required with a minimum of one year specimen processing and collection experience in a central laboratory or medical facility.BLS and/or ACLS certification preferred.Phlebotomy certification preferred but not required.Basic computer skills, including a knowledge of Microsoft Office, are required.Bilingual skills are preferred but not required.RequirementsMaintain current licensure, registration and/or certification within educational background.Maintain current BLS and/or ACLS certification.Maintain necessary CEU’s for registration and/or certification.Assist in the training of Pharmacokinetic Laboratory Staff in duties at the clinic.Actively participate on site’s ongoing Quality Assurance Program, HIPAA, and Compliance ProgramsAttend all appropriate team meetings regarding study protocols.Read and understand policy and procedures manuals, SOP manual and employee handbook.