Summary: The Clinical Research Nurse provides nursing standard of care in a research environment; Responsible for monitoring study participants, which includes collecting and reporting data on changes in their physical and mental status monitoring drug action and side effects, collecting lab sampling, dispensing, and accounting for investigational product assigned. Provides support to the clinical research coordinator in conducting inpatient portion of clinical trials; extent determined by experience, assignment of duties at the site delegation log, training, and license.
Duties and Responsibilities: The Clinical Research Nurse:
Obtains, processes, and ships laboratory samples (e.g., blood, urine, etc.) as per protocol. Assists and supports patient education on completion of diary, questionnaires and logs required in trial (if applicable) Provides nursing standard of care in subjects admitted and seen in a clinical research setting, with the supervision of clinical research nurse-registered nurse (when applicable) Ensures subjects’ safety and compliance with the protocol specific lifestyle guidelines.Obtains and maintains intravenous access on subjects admitted.Administers investigational product.Assesses adverse events and drug reactions – seeks medical intervention for patients when appropriate.Reports all adverse events (AEs), and serious or unexpected adverse events (SAEs) to the investigator and assisting the Investigator in reporting to the Sponsor/IRB all AEs/SAEs, as the protocol and regulations requirePerforms all protocol related procedures including, but not limited to vital signs, ECGs, phlebotomy, finger sticks, mouth swabs, spirometry, urine dipsticks, drug screens, pregnancy tests, etc.Adequately documents study procedure collection via progress notes, adverse event information observed and/or reported along with procedures performed during clinical trial.Obtains lab reports, procedure reports and ensure investigator reviews all lab results in form of full signature along with providing clinical significance to any out of range and/or abnormal value.Dispenses and monitor allowed concomitant medication intake. Dispenses and monitor cigarette intake. Inventories of Medical supplyConducts Quarantine and recall procedures. Maintains Crash cart inventory and contents.Facilitates DRP and ER plans in the event of an emergency. Attends Site initiation visits and/or training in-service for all protocols.Maintains current Safe-t-pack biohazard training certification or IATA equivalent, (ACLS) advance life support certification, OSHA, and site’s SOP (SWP) training. Has in-depth knowledge of company SOPs, ICH GCP guidelines and protocols assigned, specifically inpatient segment and safety criteria.Assists in documentation of medical and surgical history, concomitant medication use, preliminary complaints, and lifestyle practices. Documentation of inpatient activities, progress notes, adverse events observed and/or reported and performed during clinical trial.Supports reinforcement of study restrictions, diets, and study guidelines Assists in obtaining lab reports, procedure reports and filing, specifically day -1 and/or unscheduled collected while inpatient.Assists in preparation of collection tubes, vials, and study supplies for visits, including PK/PD set up.Continuous observation and patient monitoring to ensure subjects’ safety and compliance with the protocol, restrictions, and specific guidelines. Conducts assessment procedures as required by protocol (vital signs monitoring, electrocardiogram, etc.) under CRC and/or nurse supervision. Maintains inpatient temperature Freezer, Refrigerator, and room logs. Reports Temperature ExcursionsOccasional travel to Company sites, Principal Meetings, and/or Company meetings.Performs other duties as assigned.This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.
Requirements:
Active Registered Nurse (RN) or Licensed Vocational Nurse (LVN) licensure.Previous research experience and/or background are preferred. ACLS certification for RNs Basic Cardiac Life SupportThe Research Nurse is expected to maintain nursing license, ACLS certification for RNs and a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices.Continuing Education:
GCP (Good Clinical Practice) – Must renew every 3 yearsIATA (dangerous goods handling) – Must renew every 2 yearsCompetency Requirements:
Strong organizational and time management skills.Excellent attention to detail and ability to maintain accurate records.Effective communication skills, both written and verbal.Ability to work independently and collaboratively in a team environment.Proactive problem-solving skills and adaptability in a dynamic setting.Technical Competency Requirements:
Understanding of ICH/GCP guidelines for human researchUnderstanding of Code of Federal Regulations for Human Subject Computer Competency in Electronic Data CaptureUnderstanding Phases I-IV drug development process.ECG, Phlebotomy skills and other technical skills related to completion of study visits as required by the protocol.Physical Requirements and/or environmental factors:
Prolonged periods of sitting at a desk and working on a computerMust be able to lift 20 pounds at a time.Exposure to human bodily fluids.Laboratory Processing Procedures.Subject/Patient CareMid-level Computer use.Weekend work schedules as needed. Work is normally performed in a typical interior clinical/office environment.Travel to sponsor required meetings as needed. Read LessSummary: The Clinical Dialysis Research Nurse provides nursing standard of care in a research environment, specifically related to dialysis treatments. The nurse is responsible for monitoring study participants, which includes collecting and reporting data on changes in their physical and mental status, monitoring drug actions and side effects, collecting lab samples, dispensing, and accounting for investigational products assigned. The Dialysis Research Nurse provides support to the Clinical Research Coordinator in conducting the inpatient portion of clinical trials, with the extent of duties determined by experience, assignment of duties in the site delegation log, training, and licensure.
Duties and Responsibilities: The Clinical Dialysis Research Nurse:
Obtains, processes, and ships laboratory samples (e.g., blood, urine, etc.) as per protocol, with a focus on samples relevant to dialysis treatments.Assists and supports patient education on the completion of dialysis-related diaries, questionnaires, and logs required in the trial (if applicable).Provides nursing standard of care in subjects admitted and seen in a clinical research setting, with supervision from the Clinical Research Nurse-Registered Nurse (when applicable) during dialysis treatments.Ensures subjects’ safety and compliance with the protocol-specific lifestyle guidelines related to dialysis.Obtains and maintains intravenous access on subjects admitted for dialysis-related clinical trials.Administers investigational products during dialysis treatments as per protocol.Assesses adverse events and drug reactions related to dialysis and seeks medical intervention for patients when appropriate.Reports all adverse events (AEs) and serious or unexpected adverse events (SAEs) to the investigator and assists the Investigator in reporting to the Sponsor/IRB all AEs/SAEs, as required by the protocol and regulations.Performs all protocol-related procedures, including but not limited to vital signs, ECGs, phlebotomy, finger sticks, mouth swabs, spirometry, urine dipsticks, drug screens, pregnancy tests, etc., during dialysis research visits.Adequately documents study procedure collection via progress notes, adverse event information observed and/or reported, along with dialysis-related procedures performed during clinical trials.Obtains lab reports, procedure reports, and ensures the investigator reviews all lab results, including full signatures and providing clinical significance to any out-of-range or abnormal values in dialysis treatment results.Dispenses and monitors allowed concomitant medication intake during the dialysis research protocol.Dispenses and monitors cigarette intake as per study guidelines for dialysis patients.Manages inventories of medical supplies related to dialysis care.Conducts quarantine and recall procedures for dialysis-related supplies and medications.Maintains crash cart inventory and contents, ensuring all dialysis-related emergency equipment is available and properly stocked.Facilitates DRP and ER plans in the event of an emergency during dialysis procedures.Attends site initiation visits and/or training in-service for all protocols, specifically those involving dialysis treatments.Maintains current Safe-t-pack biohazard training certification or IATA equivalent, ACLS certification for RNs, OSHA, and site’s SOP (SWP) training.Has in-depth knowledge of company SOPs, ICH GCP guidelines, and protocols assigned, specifically the inpatient segment, safety criteria, and dialysis care requirements.Assists in documentation of medical and surgical history, concomitant medication use, preliminary complaints, and lifestyle practices of dialysis patients.Documents inpatient activities, progress notes, adverse events observed and/or reported, and dialysis-specific procedures performed during clinical trials.Supports the reinforcement of study restrictions, diets, and study guidelines for dialysis patients.Assists in obtaining lab reports, procedure reports, and filing, specifically those collected during Day -1 or unscheduled dialysis-related activities.Assists in the preparation of collection tubes, vials, and study supplies for dialysis-related visits, including PK/PD setups.Continuously observes and monitors dialysis patients to ensure safety and compliance with the protocol, restrictions, and specific dialysis-related guidelines.Conducts assessment procedures as required by the protocol (vital signs monitoring, electrocardiogram, etc.) under CRC and/or nurse supervision during dialysis sessions.Maintains inpatient temperature freezer, refrigerator, and room logs to ensure proper storage of dialysis-related medications and samples.Reports temperature excursions for dialysis-related medications and supplies.Occasional travel to company sites, Principal Meetings, and/or company meetings may be required.Performs other duties as assigned.This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.
Requirements:
Active Registered Nurse (RN) or Licensed Vocational Nurse (LVN) licensure.Previous research experience and/or background, especially in dialysis care, is required.ACLS certification for RNs.Basic Cardiac Life Support (BCLS) certification.The Dialysis Research Nurse is expected to maintain nursing license, ACLS certification for RNs, and a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, and dialysis-specific protocols.Continuing Education:
GCP (Good Clinical Practice) – Must renew every 3 yearsIATA (dangerous goods handling) – Must renew every 2 yearsCompetency Requirements:
Strong organizational and time management skills.Excellent attention to detail and ability to maintain accurate records.Effective communication skills, both written and verbal.Ability to work independently and collaboratively in a team environment.Proactive problem-solving skills and adaptability in a dynamic setting.Technical Competency Requirements:
Understanding of ICH/GCP guidelines for human researchUnderstanding of Code of Federal Regulations for Human Subject Computer Competency in Electronic Data CaptureUnderstanding Phases I-IV drug development process.ECG, Phlebotomy skills and other technical skills related to completion of study visits as required by the protocol.Physical Requirements and/or environmental factors:
Prolonged periods of sitting at a desk and working on a computerMust be able to lift 20 pounds at a time.Exposure to human bodily fluids.Laboratory Processing Procedures.Subject/Patient CareMid-level Computer use.Weekend work schedules as needed. Work is normally performed in a typical interior clinical/office environment.Travel to sponsor required meetings as needed.Equal Opportunity: The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.
Read LessSummary: The Principal Investigator (PI) will be responsible for overseeing and leading clinical trials from start to finish, ensuring scientific integrity, participant safety, and adherence to all regulatory requirements. The PI will manage all aspects of clinical research, including the development of protocols, study implementation, data management, and compliance with regulatory standards.
Duties and Responsibilities: The Principal Investigator:
Attends Site Initiation Visits and/or training in-service for all current protocols.Completes required SOP training.Oversees and directs the study tasks delegated to the clinical team, ensuring full involvement and adherence to protocol and regulatory requirements. This includes assigning tasks and ensuring all team members follow protocols.Provides leadership and guidance to the clinical research team as needed, ensuring compliance with clinical trial protocols and high standards of performance.Supervises and assists in the training and development of the clinical team and support staff for clinical trials, ensuring everyone is appropriately trained and knowledgeable.Oversees recruitment efforts for clinical trials, ensuring that recruitment is in line with study goals and regulatory requirements. This may involve providing guidance and resources to assist the recruitment process.Sets schedules to accommodate patients onsite and/or offsite as necessary, which may include weekends and holidays.Conducts the informed consent process according to SOPs, ensuring the most current ICF version is used.Evaluates the eligibility of patients for inclusion in clinical trials, ensuring thorough and accurate assessment.Conducts Psychiatric evaluations to assess suitability for participation in clinical trial. Collects medical and surgical history, concomitant medication use, and adverse event information from participants.Conducts and assesses various Psychiatric scales per protocol such as PANNS, SCID, MINI, CGI-S, CSSRS, HAM-D, HAM-A.Documents source documents, inpatient activities, visit progress notes, and adverse events, maintaining accurate and complete records throughout the study.Reviews lab results, assesses clinical significance for any out-of-range or abnormal values, and signs off as appropriate.Evaluates the appropriateness of patient inclusion into trials, order repeat labs if necessary, or screen-fail patients as needed. Provides guidance on appropriate medical care when necessary.Reinforces study restrictions, diets, and study guidelines to participants.Conducts daily rounds of inpatient unit to assess current Psychiatric status of subjects, collect AE’s and manage subjects per protocol and standard of care. Reviews and provides insight into upcoming CRFs, electronic CRFs, data clarification forms, and/or data queries.Reviews source documents, lab results, and procedures throughout the study, ensuring the integrity of trial data.Assesses adverse events and drug reactions, thoroughly recording details, including the relationship to the study drug.Assists in reporting any serious adverse events (SAEs) to the PI or relevant parties as needed.Participates in monthly staff meetings to discuss progress, challenges, and updates regarding ongoing trials.Reads and understands the information in the Investigator’s Brochure (IB), including the potential risks and side effects of the drug or treatment being studied.Performs Clinical Research Coordinator duties as needed, supporting clinical trial activities.Occasionally travel to Company sites, Investigator meetings, and/or Company meetings as required.Perform other miscellaneous job-related duties as assigned by your manager.This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.
Requirements:
Must possess a valid medical license and be board-certified in a relevant medical field.Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.), Psychiatrist or equivalent degree in a relevant medical or scientific field.Current DEA license Minimum of 5 years of clinical research experience, with at least 2 years in a leadership or supervisory role in clinical trials.Minimum of 5 years of clinical experience in managing subjects with depression, schizophrenia, and bipolar disorders. In-depth understanding of safety reporting procedures and the ability to assess adverse events.In-depth knowledge of federal regulations regarding responsibilities of a Principal Investigator. The Investigator is deemed competent when he/she can thoroughly manage project, read and understand the available information (IB) on the product under investigation, including the potential risks and side effects of the drug and possesses the ability to adhere to the study protocol and investigate the drug under investigation.Continuing Education:
GCP (Good Clinical Practice) – Must renew every 3 yearsIATA (dangerous goods handling) – Must renew every 2 yearsOSHA trainingsCompetency Requirements:
Excellent communication skills.Planning/organizational skills.Customer service skills.Attention to detail and ability to follow clinical research protocols.High level of professionalism and ethical conduct in clinical research and patient interaction.In depth knowledge of FDA-GCP regulations pertaining to protecting human rights and safety, ethical issues and clinical assessments when dealing with clinical research and human volunteers.Physical Requirements and Environmental Factors:
Approximately 20% travel required.Mid-level computer useNight/weekend work schedulesWork is normally performed in a typical interior clinical/office environment.Prolonged periods of sitting at a desk and working on a computer.Lifting of 20 pounds and occasionally more than 20 pounds. Read Less