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Clinical Research Coordinator
2 months ago
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.
- 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.
- 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.
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.