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Clinical Trials Coordinator

2 months ago

Richmond, Virginia, United States Clinical Research Partners, LLC Full time
Job Overview

Position Summary

The Clinical Trials Coordinator plays a vital role in the management and execution of clinical research projects under the guidance of the Principal Investigator and the Lead Clinical Research Coordinator.

Key Responsibilities

  • Fulfill necessary training requirements, including IATA/HAZMAT, sponsor-specific training modules, GCP, and eCRF training courses.
  • Oversee the screening and recruitment of participants for clinical trials, utilizing a thorough understanding of current protocols and eligibility criteria.
  • Facilitate the informed consent process, ensuring potential participants are well-informed and their questions are addressed.
  • Provide education to participants regarding protocol-related procedures and assessments.
  • Accurately collect, organize, and maintain data and test results for comprehensive source documentation.
  • Assist in monitoring the health status of study participants and contribute to the development of treatment plans as per research protocols.
  • Conduct necessary assessments and ensure compliance with protocol schedules during participant visits.
  • Perform blood draws when required and manage specimen processing and shipping in accordance with sponsor guidelines.
  • Complete source documents and accurately enter data into the CRF or eCRF.
  • Collaborate closely with sponsor monitors during site initiation and monitoring visits, addressing queries as needed.
  • Maintain drug accountability records and dispense study medications following protocol requirements.
  • Handle miscellaneous tasks, including maintaining temperature logs for drug storage and freezers.
  • Conduct study close-out visits, ensuring proper drug accountability and the shipment of study medications.
  • Manage IRB submissions, SAE reporting, and continuing approval reports.
  • Maintain Trial Master Files and ensure documentation complies with Regulatory Retention Requirements.

Knowledge, Skills, and Abilities

  • Ability to comprehend and follow both oral and written instructions, typically acquired through a high school education and medical assistant training.
  • Source and pre-screen viable study subjects to meet current research needs.
  • Conduct chart reviews and contact subjects for screening appointments.
  • Possess knowledge of all active studies within the organization.
  • Manage incoming calls related to recruitment and schedule pre-screening visits.
  • Develop prescreening forms for use during recruitment campaigns.
  • Conduct recruitment calls on days without patient appointments.
  • Document all recruitment efforts in a communication log and submit to the Lead CRC daily.
  • Organize and maintain all study supplies, including lab kits and study binders.

Qualifications

  • High School Diploma or GED equivalent.
  • Certification from an accredited Medical Assistant Program or higher.
  • Clinical research certification (ACRP, SoCra) is advantageous.

Employment Type

Full-time

Company Overview

This position is affiliated with Clinical Research Partners, LLC, a company dedicated to providing innovative solutions in clinical research. We pride ourselves on creating a supportive environment for both our staff and study participants, ensuring the highest standards of care and comfort.