Clinical Research Coordinator, SOM, DOIM, Division of Cardiology
Virginia Commonwealth University
Richmond, VA
Full-time
Research
Posted on May 17, 2024
Clinical Research Coordinator ( 2 positions)
School of Medicine, Internal Medicine/Pauley Heart Center
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) and Cardiology Research Nurse Manager, 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.
Required job functions include and are not limited to the following:
• Demonstrate understanding of clinical research coordinating duties from study 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
• Evaluate patients for eligibility to participate in various programs to treat
cardiovascular disease - Review medical records pertaining to these patients and present this 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, & institutional guidelines, according to all HIPAA, GCP, and other applicable requirements - Activities include coordinating new study activation requirements, screening/enrolling participants, regulatory and compliance requirements, maintaining appropriate study documentation/records, and managing study data
• 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
Required Education and Experience:
• 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 Education and Experience
• 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
Job Specific Physical and Cognitive Requirements
Light lifting (less than 20lb), fast pace, multiple stimulation, intense customer interaction, frequent change, memory, reasoning, hearing, reading, analyzing, logic, and verbal and written communication
Additional Information:
Hours / weeks: 40 hours weekly
Days /hours: Monday – Friday, Generally 8:00 am - 5:00 pm
Title Details:
University Title: Clinical Research Coordinator (1-3)/Senior Clinical Research Coordinator (1-3)
Job Codes: 34111N-34116N
University Job Family: Research & Innovation
Position Number: TBD
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.
Salary Range: $55,000-$75,000
Position Details:
Department: School of Medicine, Cardiology
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE: 1
Exemption Status: Exempt
Contact Information:
Contact Name: Demetria Patterson
Contact Email: demetria.patterson1@vcuhealth.org
Contact Phone:
