Clinical Research Coordinator SOM DOIM Division of Cardiology

4 weeks ago

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

We are seeking a highly skilled Clinical Research Coordinator to join our team at the Virginia Commonwealth University School of Medicine. As a Clinical Research Coordinator, you will play a critical role in coordinating clinical research studies in a compliant and efficient manner.

Key Responsibilities
  • Coordinate clinical research studies from initiation to close-out
  • 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), Clinical Research Coordinator, plus additional sponsor GCP certifications as required
  • Work independently and closely with patients and physicians to evaluate patients for eligibility to participate in various programs to treat cardiovascular disease
  • Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols
  • 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 database of study personnel certifications, CVs, biosketches, licenses etc. 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 & 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; establishing and maintaining productive relationships with VCU colleagues and all customers and contacts necessary to effectively support research studies
  • Must be able to prioritize work requirements and multi-task in fast-paced environment, seeking guidance from Principal Investigators and senior study team staff when necessary
  • 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.

Virginia Commonwealth University is an equal opportunity, affirmative action university providing access to education and employment without regard to race, color, religion, national origin, age, sex, political affiliation, veteran status, genetic information, sexual orientation, gender identity, gender expression, or disability.

The School of Medicine continuously strives for our workplace and learning environment to reflect the demographic and social milieu of the communities we serve. All qualified applicants are encouraged to apply.

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