Virginia Commonwealth University - Richmond, VA

posted 2 months ago

Full-time - Mid Level
Richmond, VA
Educational Services

About the position

The Sr. Clinical Research Coordinator at Virginia Commonwealth University (VCU) School of Medicine plays a crucial role in the Translational Research Program in Muscular Dystrophy. This position is responsible for coordinating clinical research activities from initiation to closeout, ensuring compliance with all regulatory requirements, and supporting the Principal Investigator and research team in achieving the program's objectives. The role involves managing participant recruitment, data management, and regulatory compliance while fostering a diverse and inclusive environment.

Responsibilities

  • Independently coordinate study recruitment activities including pre-screening and screening.
  • Conduct and document the informed consent process for research participants throughout their participation.
  • Coordinate the enrollment of participants and manage randomization documents.
  • Support the Principal Investigator and study staff in ensuring compliance with study activities.
  • Assist in the orientation and training of new research team members.
  • Ensure completion of all required study close-out activities.
  • Manage clinical research processes and documentation, including filing and scheduling.
  • Understand and adhere to human subject protection and IRB regulations.
  • Participate in meetings with monitors to ensure data accuracy and compliance.
  • Coordinate auditing and monitoring activities for assigned studies.
  • Assist in the management of study data and maintain study files according to GCP guidelines.
  • Ensure timely entry of subject data into required systems and respond to queries.
  • Complete required orientation and training modules for clinical research projects.
  • Conduct clinical activities as approved and maintain required competencies.

Requirements

  • Bachelor's Degree or equivalent related 5+ years experience.
  • Ability to obtain Clinical Research Coordinator certification (CCRC, CCRP, CCRA) within one year of hire date.
  • Ability to obtain CNA, CMA or EMT within 6 months of hire date.
  • Highly competent with computer software, including database, spreadsheet and word processing applications.
  • Demonstrated experience working in and fostering a diverse faculty, staff, and student environment.

Nice-to-haves

  • Master's Degree
  • RN, LPN, CAN, CMA or EMT with active license
  • Experience in human subjects research in participants with neurological disorders
  • Familiarity with eTMF software, RedCap, RedCap Cloud and/or other EDC
  • Experience administering validated survey instruments.

Benefits

  • Health, vision, and dental coverage
  • Life insurance
  • Short and long-term disability coverage
  • Retirement planning
  • Tax-deferred annuity and cash match programs
  • Flexible spending accounts
  • Tuition benefits
  • Significant paid-time off
  • 12 paid holidays
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