Clincial Research Coordinator

Clinical Research Coordinator, School of Medicine, Department of Internal Medicine

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education. VCU School of Medicine comprises 18 clinical departments, eight basic health science departments, and 11 affiliated institutes and centers, and provides preeminent education to physicians and scientists in order to improve the quality of healthcare for humanity. All full-time university staff are eligible for our generous benefits package that includes choices for 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, and more. Explore our benefits further here: https://hr.vcu.edu/current-employees/benefits/university-and-academic-professional-benefits/

Position Summary

For all clinical research studies assigned, the Clinical Research Coordinator is responsible for coordinating clinical research studies in a compliant and efficient manner. Under the direction of the Principal Investigator (PI), collaborate with all members of the clinical research team to ensure all federal, state, university, and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept. Demonstrate understanding of clinical research management duties from study initiation to close-out.

Required Duties:

The primary duties are general administration, regulatory and compliance requirements, new study activation study conduct, data management and documentation, and clinical skills. This includes and is not limited to the following:

• For assigned studies, coordinate clinical research processes and documentation which may include: filing and office organization, research participant scheduling, ordering of study materials and supplies, and schedule of meetings
• Coordinate and/or prepare and collect all necessary study documentation which may include: feasibility forms, pre-screening logs, screening logs, enrollment logs, medication log, adverse event log, delegation of authority log, training logs, etc.
• Design and implement optimal systems to identify potential research subjects for assigned studies
• Understand and adhere to all human subject protection and IRB regulations required for clinical research. Understand duty to report obligations related to research conduct, and the appropriate university channels for reporting concerns
• On behalf of Principal Investigators (PI), prepare RAMS-IRB (and WIRB as applicable) submissions including: initial, continuing, amendments, safety reports, serious adverse event reporting
• Participate in SOM study activation activities and follow-up action items. Coordinate with study PIs to provide information to support development/finalization of coverage analysis and budget documents; time/effort estimates, billing plan assessment, etc
• Coordinate subject recruitment activities: pre-screening and screening
• Coordinate the registration and enrollment of participants, coordinate and file registration/randomization documents; notifying applicable/allowable individuals of registration/randomization results (PI, participant, study team, pharmacist, etc.)
• Support the PI and other senior study staff in following study participants through all study activities to ensure that the study is conducted in compliance with all requirements
• Assist the PI and senior study team members in the management of study data for new and ongoing clinical research studies assigned
• Maintain study files according to GCP guidelines and in audit ready condition
• Complete VCUHS orientation and training modules as required for the department & clinical research projects
• Conduct applicable clinical activities only as approved & required for each clinical research project

Required Education. Experience and Abilities:

• Demonstrated knowledge and understanding of clinical research management to include: regulatory, human subject’s protection, study conduct, and data management requirements
• Excellent communication, writing, and interpersonal skills
• Exhibits professionalism and ability to work both independently and collaboratively as part of a team; establishing and maintain 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 the Lead Research Coordinator for the Department of Internal Medicine, 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 manage complex clinical trials, including those enrolling participants with high-acuity healthcare needs
• 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 Education and Experience:

• Bachelor’s degree in a scientific/healthcare field strongly preferred, or a combination of education and at least 3 years of experience in a clinical research role
• At least 1 year of experience coordinating clinical research
• Familiarity with EPIC and VCU Health System
• CNA, CMA, EMT, SoCRA or ACRP Certified

Job Specific Physical and Cognitive Requirements:

Light lifting (less than 20 lb), fast pace, multiple stimulation, intense customer interaction, frequent change, memory, reasoning, hearing, reading, analyzing, logic, and verbal and written communication

Additional Information:

ORP Eligible: - No

Hours / weeks - 40 hours weekly

Days /hours - Monday - Friday, Generally 8:00 am - 5:00 pm

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

Position will remain open until candidate is selected.

Title Details:

University Title: Clinical Research Coordinator

University Job Family: Research and Innovation

Position numbers: 578970

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.