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• A

  Safety Associate  

  Allen Spolden

  - New York City

  Posted: 03/06/2026

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  Job DescriptionThe Safety Associate provides technical and process-rel... Read More

  Job Description
  The Safety Associate provides technical and process-related support to clinical trial safety management and medical monitoring activities, ensuring compliance with applicable regulatory requirements and Standard Operating Procedures (SOPs). This role requires sound judgment and professional knowledge to ensure complete, accurate and timely safety reporting.
  
  Serve as resource for protocol-specific and/or general clinical trial safety reporting requirementsAssist with writing or reviewing safety monitoring documents, including safety management plans.Manage the receipt and processing of adverse event reports (i.e., SAE, UADE, AESI, pregnancy case and/or other protocol-specified case reports) to include entry of safety data into adverse event database(s) as required and tracking systems as well as review of adverse events for completeness, accuracy and appropriateness for expedited reportingDevelop and coordinate resolution of safety data queries; obtain supplemental documents as neededWrite patient narratives and draft MedWatch and/or CIOMS Forms as neededCoordinate Medical Monitor review of safety data; extract data from the study database or external data portal and prepare data listings as neededProvide safety reports to the sponsor and project team members (i.e., Project Manager, Biostatistician, Medical Writer) as required and/or outlined in approved Safety Management PlansAssist with the unblinding of treatment assignment as neededComplete medical coding, once trained, as neededAssist with safety data reconciliation as assignedMaintain safety records and associated documentation in approved systems as requiredActively participate in project meetings as required and represent safety services at bid defenses when requestedAttend Investigator meetings and/or present safety reporting requirements as neededFacilitate CEC/DMC/DSMB meetings and performs associated tasks as assignedAssist with project safety service proposal development as assignedMaintain expertise through continuing education and review of current industry literatureSupport other company initiatives and cross-functional team projects as assignedPerform other duties as assigned
  Requirements
  A Bachelor's degree, preferably in science or a health-related field, with at least three years of drug safety experience is preferred; however, a combination of education, training and experience will be consideredMedDRA coding certification is preferredStrong knowledge of US federal regulations, ICH guidelines, and HIPAA as applicable to safety reporting in clinical trialsStrong computer skills with knowledge of safety database management and clinical data management systems; proficiency in at least two EDC platforms is preferredExcellent interpersonal skills and ability to work well with sponsor representatives, Medical Monitors, clinical investigators and site personnel and multidisciplinary project team membersExcellent communication skills (verbal/written/presentation)Proven ability to plan, prioritize, and manage a workload independently with a high degree of initiative and attention to detailDemonstrated problem solving skills including successful resolution and proactivity
  Communications
  
  Communicates effectively and objectivelyProfessional and effective team and sponsor communicationAble to present to large groups, including peers, team members and other project-related personnelOrganizes, participates and facilitates internal and external meetingsMaintains electronic files that can be accessed by appropriate personnelUses applicable systems to communicate with personnel Read Less

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• A

  Clinical Research Associate 1  

  Allen Spolden

  - Charleston

  Posted: 03/06/2026

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  Job DescriptionResponsible for providing Clinical Research support for... Read More

  Job Description
  Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
  
  Essential Duties And Responsibilities
  
  Participate and assist in design and preparation of protocols and case report forms.Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.Participate in the evaluation of potential clinical sites according to established criteria of acceptability.Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.Assist with the maintenance of clinical archive and electronic files.Other tasks as assigned.
  Requirements
  
  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
  BA, BS, RN, BSN or equivalentBasic knowledge and adherence to GCPs1-2 years of clinical research experience or equivalent experience or trainingStrong attention to detailAbility to multi-taskUnquestionable integrity and highest ethical standardsExcellent written and verbal communication skillsSelf-motivated, assertive, and driven
  Benefits
  
  Dental, Medical, Vision, PTO and 401K Read Less

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• A

  Clinical Trial Associate  

  Allen Spolden

  - New Brunswick

  Posted: 03/06/2026

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  Job DescriptionThe remote-based Clinical Trial Associate (CTA) will pe... Read More

  Job Description
  The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.
  
  Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager.Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.Perform departmental tasks.Perform developmental tasks with oversight of CTA Manager.
  ACCOUNTABILITIES:
  
  For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:
  
  Approval of study documentation, including essential document packets, study plans, informed consent forms, etc.Support oversight of risk-based monitoring.Attend important team meetings.Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.)Support additional ad-hoc activities, as agreed with CTA Manager.Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors.Escalate clinical trial insurance issues.Support Health Care Provider Engagement for facilitating contracts and meetings.Support vendor contract administration.
  Requirements
  Bachelor's degree or equivalent international degree.1 or more years' experience in pharmaceutical industry, clinical research organization, or related role.Experience in Phase 2 and 3 studies and global/international studies is advantageous.Experience working across multiple therapeutic areas is advantageous.Knowledge in global regulatory and compliance requirements for clinical research.Excellence in task management and collaboration.Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis.
  Benefits
  401(k) with company match and Annual Retirement Contribution PlanTuition reimbursement Company match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs Read Less

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• A

  Quality Manager  

  Allen Spolden

  - Sacramento

  Posted: 03/06/2026

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  Job DescriptionPrimary Responsibilities:Make patient assessments in ho... Read More

  Job Description
  Primary Responsibilities:
  
  Make patient assessments in home setting and determining appropriate levels of behavioral care neededObtain information from providers on outpatient requests for treatmentDetermine if additional clinical treatment sessions are neededManage behavioral health cases throughout the entire treatment planAdminister benefits and review treatment plans in collaboration with interdisciplinary care teamAssist in coordinating Medicaid/Medicare benefits and transitions between various areas of careCommunicate with members who have complex medical needs and may have communication barriersIdentify ways to add value to treatment plans and consulting with facility staff or outpatient care providers on those ideasFocus on whole person care model for psychiatric and chemical dependency patientsBuild relationships and work with a variety of populations within the communityAbility to work with low - income populations with complex social and medical needs including adults with serious mental illness and emotional disturbances, members with substance use disorders, and members with other complex or multiple chronic conditions
  You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
  
  Requirements
  
  Required Qualifications:
  
  Master's degree in Social Work1+ years of clinical or case management experience2+ years of experience in long-term care, home health, hospice, public health or assisted livingExperience working with MS Word, Excel and OutlookFull COVID-19 vaccination is an essential job function of this role. Candidates located in states that mandate COVID-19 booster doses must also comply with those state requirements. UnitedHealth Group will adhere to all federal, state and local regulations as well as all client requirements and will obtain necessary proof of vaccination, and boosters when applicable, prior to employment to ensure compliance. Candidates must be able to perform all essential job functions with or without reasonable accommodation
  Preferred Qualifications:
  
  LCSW licenseProven background in managing populations with complex medical or behavioral needsExperience with electronic chartingExperience with arranging community resourcesField based work experienceDemonstrated knowledge of both medical and behavioral health diagnosis and terminologyProven knowledge of symptom identification and intervention, associated with behavioral health and substance use disordersProven knowledge of APS reporting processesExperience working with complex family systems and dynamicsProven knowledge of resources to address SDOHExperience in crisis interventionProven understanding of health disparities among various membership, based on their race or ethnicity; religion; socioeconomic status; sexual orientation; gender, gender identity; age; mental health; cognitive, sensory or physical disability; geographic location or other characteristics historically linked to discrimination and exclusionExperience working in Duals (DSNP) and/or Medicaid environmentAbility to work independently as well as a member of a teamExcellent written and verbal communication and relationship building skillsPlanning and organizational skillsProficient with Microsoft Word, Excel, Outlook, PowerPoint
  Benefits
  
  Dental, Medical, Vision and 401K Read Less

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