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Clinical Research Coordinator

2 months ago


Richmond, Virginia, United States Commonwealth of Virginia Full time
Job Summary

We are seeking a highly skilled and detail-oriented Clinical Research Coordinator to join our team at the Commonwealth of Virginia. The successful candidate will be responsible for coordinating clinical research studies in a compliant and efficient manner.

Key Responsibilities
  • Coordinate clinical research studies from initiation to close-out, ensuring compliance with federal, state, and institutional regulations.
  • Collaborate with the Principal Investigator, Cardiology Research Nurse Manager, and other team members to ensure all requirements are met.
  • Conduct clinical research activities as authorized by the Principal Investigator's documented Delegation of Authority and Training Logs.
  • Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), and Clinical Research Coordinator certifications.
  • Work independently and closely with patients and physicians to evaluate patients for eligibility to participate in various programs to treat cardiovascular disease.
  • Review medical records and present data to the attending physician group for review.
  • Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB-approved protocols.
  • Conduct all assigned activities in compliance with national, local, and institutional guidelines, according to all HIPAA, GCP, and other applicable requirements.
  • Coordinate various clinical research programs dealing with diagnostic and therapeutic aspects of cardiovascular disease and its complications under the direction of physicians within the Cardiology Division.
  • Maintain a database of study personnel certifications, CVs, biosketches, licenses, and collect data for all required regulatory agencies and studies accurately and on time.
  • Assist the PI and senior study team members in the management of study data for new and ongoing clinical research studies assigned.
  • Ensure patient safety is a top priority in conducting clinical trials.
  • Support PIs with human subject protection applications to IRB.
  • Ensure all IRB submissions are complete and submitted on time.
  • Assist with completion of initial IRB submissions, annual continuing reviews, amendments, and reliance agreements for clinical trials.
  • Prepare FDA submissions (1572, IND, IDE, HUD, etc.).
  • Prepare and submit essential study documents for clinical trials.
  • Assist with protocol and informed consent creation.
  • Maintain regulatory binders in audit-ready state, ensuring all documentation is complete and has been submitted to the IRB.
  • Provide timely and courteous responses to queries from patients, faculty, and sponsors.
  • Work with other Divisional research coordinators, sub-investigators, and study staff, and with other clinicians at all VCU sites involved in the research, to coordinate care of patients and to ensure consistency in treatment.
  • Complete VCUHS orientation and training modules as required for the department and clinical research projects.
Requirements
  • Excellent communication, writing, and interpersonal skills.
  • Exhibits professionalism and ability to work both independently and collaboratively as part of a team.
  • Must be able to prioritize work requirements and multi-task in a fast-paced environment.
  • Ability to read, interpret, and apply complex regulations, policies, and requirements for each study assigned.
  • Excellent organization, time management, and critical thinking skills.
  • Able to provide own transportation to service areas and meeting locations.
  • Ability to participate in professional education and advancement opportunities to facilitate personal and program growth.
  • Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.
Preferred Qualifications
  • Previous patient care exposure in a cardiovascular setting.
  • Research experience and direct patient care experience with patients with cardiovascular disease.
  • Familiarity with EPIC electronic medical records system and VCU Health.
Additional Information

This is a restricted position with no set end date and continued employment is dependent upon project needs, availability of funds, and performance.

The position will remain open until a candidate is selected.