Clinical Research Coordinator, Pauley Heart Center/Cardiology, School of Medicine

Clinical Research Coordinator
Dietitian focus
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. 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:

Position Summary:
The VCU Pauley Heart Center is seeking a highly motivated Clinical Research Coordinator (CRC) to join our dynamic research team, contributing to the successful execution of clinical research studies while specializing in key areas. The position will involve performing standard CRC duties, including coordinating studies in compliance with federal, state, university, and protocol requirements, managing participant recruitment and data collection, and collaborating with the clinical research team to ensure ethical and research objectives are met. The position requires a registered dietitian (RD) to provide specialized nutritional guidance, assess dietary intake, deliver health education, and help design nutrition-based interventions. The role will work closely with the Principal Investigator (PI) and Cardio-Oncology Research Manager to ensure studies are conducted efficiently and ethically while contributing their expertise to the success of their respective specialty areas.

Required job functions include but 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, physicians, PI's, and other cardio-oncology team members
-Evaluate patients for eligibility to participate in research in cardio-oncology
-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)
-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 cardio-oncology 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 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 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
-Must be able to complete mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training
-Ability to participate in professional education and advancement opportunities to facilitate personal and program growth
- Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from various backgrounds and experiences, or a commitment to do so as a staff member at VCU

Requirements:
-Bachelor's and/or Master's degree(s) in Nutrition, Health Sciences, or related field. Certification as a registered dietitian or planning to take RD certification exam upon graduation if currently enrolled as a student.
Preferred Education and Experience:
-Previous patient care and/or research experience in a cardiovascular or oncology setting
-Previous experience in the clinical setting assessing patients in accordance with research protocols
-Familiarity with EPIC electronic medical records system
-Previous experience in screening potential patients for research studies
-Experience in working with diverse age groups and populations
-Experience with data management and analysis and/or in statistical analysis and programming
Previous experience in personalized exercise, nutrition, and/or wellness counseling
Nutrition-specific preferred experience:
-Experience assessing body composition using a variety of modalities
-Previous experience in coaching patients in behavioral or lifestyle change intervention programs

Application Specific Information:
Please specify in your application or a cover letter which position you are applying for.
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: Clinical Research Coordinator
University Title: Clinical Research Coordinator (1-3)
Job Codes: (34111N-34113N)
University Job Family: Research & Innovation

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

Please note that if you are employed as a university employee working in any of the health system's facilities, you will need to follow VCU Health System policies, which will include but will not be limited to, vaccination requirements.
The position will remain open until a candidate is selected.

Virginia Commonwealth University is an equal opportunity employer.