Description

Position Summary and Primary Responsibilities:

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.

To support these efforts, the Pediatric Research Office is seeking a candidate with strong skills in clinical research coordination and regulatory management to join our team as a Senior Clinical Research Regulatory Coordinator (or Manager, depending on experience).

This position is a key part of the team focused on supporting pediatric clinical research study teams with the management of clinical trials in a positive and dynamic environment. Working under the direction of the Research Program Manager, key responsibilities for this position include:

Core Responsibilities

Regulatory Management and Study Activation (50%)

• Provide direct regulatory management for studies, with duties including: prepare and maintain study regulatory documents, manage ancillary committee and IRB submissions, draft study protocols, and obtain all required internal approvals (ie: SOMCT, OSP, etc.).
• Ensure study startup is carried out according to sponsor/funding agency requirements and all VCU and School of Medicine procedures for activation and management of clinical research.
• Maintain an established, portfolio driven knowledge base of FDA/GCP/ICH and guidelines, 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.
• Monitor study portfolio across life cycle to ensure adherence to all human subject protection and IRB regulations required for clinical research
• Understand reporting obligations related to research conduct and lead study team through required actions.
• Act as liaison between regulatory bodies, VCU, VCU Health, and study teams. Keep investigators and leadership informed regarding study regulatory operations and activation progress.

Support and Assist PRO Study Teams (40%)

• Provide education to investigators and study team members as it relates to regulatory compliance; lead the development of best practice guidance and work aids for CRCs in areas such as: study activation, study coordination, data management, and records management. Stay informed on internal clinical research submission policies and educate study teams on changes.
• Participate in the protocol feasibility process for new research studies. Review and evaluate protocols to identify issues/challenges and potential problems related to subject recruitment and assessment logistics; gather information for solutions; determine whether the trial is appropriate to conduct in this institution. Participate in study development/solicitation/identification to build portfolio of research that aligns with strategic goals.
• Coordinate site selection visits, study selection activities, and monitor accesses and visits.
• Participate in pre-study planning meetings and the coverage analysis and budget process for new studies and amendments. Collaborate with financial personnel to ensure appropriate information is provided to manage the research budget.
• Assist with training CRCs on required regulatory and IRB ongoing study documentation.
• 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.
• Ensure OnCore and internal project management tools are current and maintained throughout the study lifespan.
• Responsible for ensuring clinical trials are initiated and maintained in Veeva SiteVault. Provide training and assistance to study team as needed.

Excellence in Customer Service and Collaboration (10%)
• Provide ongoing support for clinical research operations and administration in the PRO including ongoing communication with departments/divisions, investigators, administrators, and staff.
• Serve as an ongoing resource for providing information and expert advice on regulatory compliance.
• Regularly assess PRO CRC performance by performing quality control checks and support staff development.
• Develop and nurture relationships with cross-functional teams including principal investigators, clinic staff, regulatory affairs, colleagues throughout VCU, SOM, and VCUHS, and study sponsors. Provide expert information and instruction to investigators, research nurses/coordinators, and support staff for the implementation of and adherence to clinical research protocols. Model, maintain, and ensure best practice in areas such as study activation, study coordination, participant enrollment and consent, and data management.
• 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.

This is a hybrid position, with in-office responsibilities in Richmond, VA.