Senior Clinical Research Coordinator, School Of Medicine/Department Of Pediatrics

Position Summary:

VCU Department of Pediatrics and Children's Hospital of Richmond at VCU are not just caring for kids and families: we're discovering new treatments, improving outcomes, and researching innovative new ideas. The Pediatric Research Office is committed to supporting VCU clinical researchers in advancing investigative medicine.

The Division of Pediatric Hematology-Oncology seeks an experienced research professional to join their team as a Developmental Therapeutic Research Coordinator. This role will assist physician-investigators in managing complex clinical trials, with a likely opportunity for continued advancement as program growth continues.

This position will report to the Program Manager and work directly with Pediatric Hematology-Oncology Physician Investigators, and other divisions as assigned. This is an experienced coordinator role, with an intention to provide project management and support to researchers with investigator initiated and/or multi-site research studies with advanced job responsibilities across a variety of clinical and research areas. As a team lead, this position will provide mentorship and training to other coordinators, with the ability to assume responsibility for oversight as support needs grow or as department needs dictate.

Core Responsibilities:

Support the ongoing advancement of the Pediatric Department and Pediatric Research Office. (25%)

• Work with leadership to identify, develop, and evaluate resources and ongoing requirements to ensure Pediatric Research Office is current on Institution and clinical research standards and can implement process improvement and updated workflows.

• Provide information, expert advice, and instruction to investigators, research nurses/coordinators, and research support staff for planning, development, implementation, conducting, monitoring, and termination of pediatric clinical research trials.

• Model the development of best practice guidance and work aids in areas such as: study activation, study coordination, participant enrollment and consent, and data management.

• Develop and nurture relationships with principal investigators, all other members of the study teams, departmental personnel, colleagues, and co-workers throughout VCU, SOM and VCUHS, and study sponsors. Participate in study development/solicitation/identification to build portfolio of Pediatric research.

Perform study implementation and coordination tasks for studies assigned. (75%)

• Maintain an established, portfolio driven knowledge base of federal and state laws and regulations, sponsor guidance, as well as university policies, compliance notices, and internal processes, with ability to consistently interpret and apply accurately.

• Independently manage complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) clinical trials and registries. Responsible for initiating investigator-initiated IND/IDE clinical trials in collaboration with faculty supervisor.

• Work directly with physicians to design, set-up, and execute studies. Coordinate with physician investigators and clinical care to recruit, monitor, and manage participants on research protocols. Ensure protocol compliance and data quality are maintained. Ensure patient safety is a top priority in the conduct of clinical studies. Be directly responsible for day-to-day clinical research management.

• Be actively involved in participant recruitment (evaluate strategies, review medical records of upcoming new and return patient clinic visits and discuss with investigators, reach out to potential referring physicians, approach potential subjects, and ask pre-screening eligibility questions, etc.). May participate in the clinic to explain a trial and conduct informed consent with the patient and family.

• Review, understand, and champion trials in portfolio. Proactively communicate with investigators for any gaps in understanding. Perform staff in-service/education for nursing and ancillary units (e.g., laboratory, radiology, Investigational Drug Service) involved in the study. Perform ongoing study management in collaboration with other medical and nursing personnel and ancillary departments.

• Serve as a liaison between industry sponsors, contract research organizations, faculty investigators, other academic medical centers, and the Institution for promoting the conduct of clinical research in the Institution and in managing expectations and workflow for specific protocols.

• Participate in the protocol feasibility process for new research studies. Review and evaluate protocols for the following: identify issues/challenges and potential problems related to subject recruitment and assessment logistics; gather information for solutions; and to determine whether the trial is appropriate to conduct in this institution.

• Work with SOM administrative activation team; independently participate in the coverage analysis and budget feasibility process for new studies and amendments. Assist with identifying the protocol procedures specific to the research and the time required for the procedure. Collaborate with financial personnel to ensure appropriate information is provided to manage the research budget.

• Complete VCUHS orientation and training modules as required for the department and clinical research projects to obtain access to VCUHS clinical systems and clinical data. Conduct applicable clinical activities only as approved for each position on the clinical permission table and required for each clinical research project. Follow all VCUHS policies & procedures, including vaccination requirements and requirements for annual training. Job duties may include: entering information into the medical record; provide documentation assistance with transcribing provider orders; performing study assessments, including point of care testing; providing documentation assistance with transcribing provider orders in EPIC; the handling, transportation, access to and/or contact with medications and related supplies; minimum qualifications include HIPAA training, EMR navigation/computerized order entry. Performance and continued competence will be periodically assessed.

• Participate in cross-training and cross-coverage for other members of the Pediatric Research Office, ensuring no lapse in administrative aspects of study management or study. Occasional ability to shift schedule to provide on-call/after-hours coverage for research projects as needed.

• Other duties as assigned.