Clinical Research Coordinator
5 days ago
We are seeking a highly skilled Clinical Research Coordinator to join our team at Hackensack Meridian Health. As a key member of our research team, you will be responsible for coordinating and overseeing clinical operations of all assigned clinical trials.
Key Responsibilities- Act as liaison between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists on all regulatory issues and changes within the protocol.
- Collaborate with the principal investigator, clinical research coordinator, and clinical team to review studies for feasibility and evaluate potential competition with other protocols prior to submitting the study.
- Review study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks, and oversee subject enrollment to ensure that informed consent is properly obtained and documented.
- Coordinate research activities, including scheduling laboratory tests, radiology testing, and other medical exams as required.
- Work with the study team to draft/create study-specific study orders, billing templates, and study calendars as necessary.
- Monitor all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
- Register protocol patients with appropriate statistical centers as required, and track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Act as principal investigator's representative as appropriate, communicating with sponsors and their representatives, the IRB, and other medical personnel.
- Maintain accurate, complete, and up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required.
- Work closely with clinical research finance to ensure study patient's clinical trial-related activities are billed appropriately.
- Schedule, coordinate, prepare, and assist for all sponsor monitor site visits and ensure all supporting documentation records are adequate and available for the visit.
- BA/BS diploma/degree in a science or healthcare field.
- Minimum of 2 years of experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years of related experience in the field of clinical research.
- Strong attention to detail and customer service focus.
- Ability to work independently or in a team and handle multiple deadline-driven tasks in a dynamic environment.
- Excellent organizational, presentation, documentation, and interpersonal skills.
- Excellent written and verbal communication skills.
- Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
- Education on human subject research and GCP.
- SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).
We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply today.
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