Clinical Research Assistant

Cooper University Health Care
  • Camden, NJ
    3 days ago

    Job Description

    About Us

    Cooper Norcross Health, formerly Cooper University Health Care, is a leading academic health system affiliated with Cooper Norcross Medical School of Rowan University. Headquartered in Camden, New Jersey, Cooper Norcross Health has revenues of more than $3 billion and an A+ credit rating from both S&P and Fitch Ratings.

    Cooper Norcross Health has nearly 14,000 team members, including more than 2,200 nurses, more than 1,200 employed physicians representing 95 specialties and subspecialties, and more than 700 advanced practice providers.

    The health system operates MD Anderson Cancer Center at Cooper as well as four hospitals - its 663-bed flagship Cooper Norcross University Hospital in Camden, its 229-bed Cooper Norcross University Hospital Cape Regional in Cape May Court House, Children's Hospital at Cooper Norcross Health in Camden, and The Recovery Village Cherry Hill at Cooper, a substance abuse rehabilitation and inpatient treatment facility, in partnership with American Recovery Services.

    Cooper Norcross University Hospital in Camden is the only Level 1 Trauma Center in South Jersey and the busiest in the region. The hospital has been recognized as a top-performing regional hospital by U.S. News & World Report's Best Hospitals annual survey for eight years.

    More than 2.54 million patients visit Cooper Norcross Health facilities annually. Its ambulatory network encompasses three outpatient surgery centers, seven urgent care centers, a wound care center, and more than 130 physician, physical therapy, and radiology offices extending from the Delaware River to the New Jersey shore.

    Cooper Norcross Health, a not-for-profit health system, was named one of America's Best Large Employers for 2026 by Forbes, ranking among the top 200 in the nation. Visit CooperHealth.org to learn more.

    Short Description

    The Clinical Research Assistant (CRA) will assist in the conduct of clinical research activities, including participant recruitment, study documentation, data collection and entry, scheduling, and administrative tasks.

    This position will work closely with, and under the direction of the Principal Investigator (PI) and research team and will perform duties consistent with training and assigned responsibilities, and delegation.

    Other responsibilities include participating in research team meetings, communicating with internal and external research team members, and providing organizational and operational support for new and ongoing clinical research studies.

    Under general supervision, the Clinical Research Assistant will assist research staff with a variety of tasks to support the accurate, efficient, and compliant conduct of clinical research studies.

    Responsibilities may vary based on study assignment, training, and delegated responsibilities.

    Study Operations:

    Support the day-to-day conduct of new and ongoing trials under the direction of the Principal

    Investigator (PI), research team and in line with the protocol.

    Screen potential participants for research studies and collaborate with the PI, Clinical Research Nurse (CRN), or Clinical Research Coordinator (CRC) for final approval of the potential study participant as a candidate for the study

    Assist with scheduling and study visit coordination, including preparing for and supporting study visits, procedures, and other study-related activities

    Conducts timely telephone follow-up calls with study participants and document communications in the appropriate place in accordance with the protocol

    Assist with tracking enrollment, study milestones, outstanding tasks, and visit requirements

    Assist with study supplies, laboratory kits, equipment, and other study materials

    Assist with the preparation of documents and materials needed for study initiation, monitoring and close-out visits with sponsors and/or Clinical Research Organization (CROs), including clerical support, copying, and gathering information

    Regulatory & Compliance:

    Assist with the preparation and submission of regulatory documents to the Institutional Review Board (IRB)

    Assist with organizing and maintaining regulatory and essential study documentation in accordance with ALCOA+ principles and study requirements, as directed by Supervisor, CRN, or CRC

    Assist the research team in preparation for sponsor/CRO monitoring visits, audits, and regulatory inspections

    Perform assigned responsibilities in accordance with study protocols, institutional policies, Standard

    Operating Procedures (SOPs), ICH-GCP, and applicable regulatory requirements

    Data Management:

    Obtain medical records and other source documentation required to complete CRFs and study documentation

    Assist with study data collection, entry, verification, and maintenance in Electronic Data Capture (EDC) systems and other designated databases

    Assist with the upload of study-related images and imaging data to designated study imaging portals

    Assist study teams with data query resolution and follow-up on outstanding data issues

    Maintain study trackers, screening and enrollment logs, visit logs, and other study-related records as assigned

    Study Logistics & Specimen Management:

    Prepare and organize study research laboratory kits and materials

    Coordinate research specimen collection, processing, storage, and delivery

    Process, prepare, package, and ship blood, saliva, tumor tissue, and other research specimens in accordance with study protocols, laboratory requirements, and shipping procedures, assist with hospital and campus research-related pickups and deliveries

    Maintain appropriate documentation and tracking of research specimens and study materials

    Collaboration and Support

    Attend study-related meetings, conferences calls, training sessions, and other research activities

    Work collaboratively with CRCs, CRNs, PIs, and other members of the research team

    Communicate and collaborate effectively with internal partners, sponsors, CROs, laboratories, IRBs, and other external research partners as directed

    Assist with email correspondence, document preparation, copying, filing, and other clerical and administrative duties as requested by CRC, CRN, or Supervisor

    Assist with identifying routine study-related issues and promptly communicate concerns to the appropriate member of the research team

    Provide organizational and administrative support to research staff to facilitate the efficient conduct of conduct clinical research studies

    Maintain participant confidentiality and comply with HIPAA, institutional privacy policies, and applicable research requirements

    Perform additional duties as assigned in support of clinical research operations

    Research Billing & Compliance

    Assist with the review of research billing charges, including UB-04 and CMS-1500 (Form 1500) billing forms, for participants enrolled in clinical research studies

    Assist with distinguishing research-related charges from standard-of-care services that may be billable to insurance or another responsible payer

    Support research billing review activities as assigned and appropriately trained

    Other Responsibilities

    Perform other duties as assigned or delegated by department leadership

    Experience Required

    0-2 years Clinical Research

    Education Requirements

    Bachelors Degree Required

    Special Requirements

    General Experience working in clinical research, public health, or behavioral science Preferred

    Strong interpersonal, communication, and organizational skills

    Ability to manage multiple tasks, meet deadlines, and adapt to a fast-paced research environment.

    Salary Min ($)

    USD $25.00

    Salary Max ($)

    USD $42.50

    Numbers & Facts

    LocationCamden, NJ

    Skills

    • Administrative Skillsunmatched
    • Behavioral Healthunmatched
    • Billingunmatched
    • Billing Recordsunmatched
    • Cancerunmatched
    • Case Report Form (CRF)unmatched
    • Certified Radiologic Nurse (CRN)unmatched
    • Clinical Data Collectionunmatched
    • Clinical Nursingunmatched
    • Clinical Researchunmatched
    • Communication Skillsunmatched
    • Conferencesunmatched
    • Content Management Systems (CMS)unmatched
    • Contract Research Organization (CRO)unmatched
    • Credit Riskunmatched
    • Data Collectionunmatched
    • Data Entryunmatched
    • Documentationunmatched
    • Electronic Data Capture (EDC)unmatched
    • HIPAA (Health Insurance Portability and Accountability Act)unmatched
    • Healthcareunmatched
    • Hospitalunmatched
    • IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
    • Insuranceunmatched
    • Interpersonal Skillsunmatched
    • Laboratoryunmatched
    • Laboratory Equipmentunmatched
    • Logistics Managementunmatched
    • Medical Recordsunmatched
    • Multitaskingunmatched
    • Operational Supportunmatched
    • Organizational Skillsunmatched
    • Outpatient Careunmatched
    • Patient Careunmatched
    • Photocopyunmatched
    • Physical Therapyunmatched
    • Prepare Correspondenceunmatched
    • Public Healthunmatched
    • Radiologyunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Submissionsunmatched
    • Research Laboratoryunmatched
    • Research Nursingunmatched
    • Research Protocolsunmatched
    • Research Skillsunmatched
    • Sample/Specimen Processingunmatched
    • Specimen Collectionunmatched
    • Specimens/Samplesunmatched
    • Substance Abuseunmatched
    • System Operationsunmatched
    • Team Playerunmatched
    • Time Managementunmatched
    • Urgent Careunmatched
    • Wound Careunmatched

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