Senior Clinical Research Regulatory Coordinator, Department of Pediatrics

Position Summary and PrimaryResponsibilities:

VCU Department of Pediatrics and Childrens Hospital of Richmond at VCU are notjust caring for kids and families: were discovering new treatments improvingoutcomes and researching innovative new ideas. The Pediatric Research Officeis committed to supporting VCU clinical researchers in advancing investigativemedicine.

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

This position is a key part of the team focusedon supporting pediatric clinical research study teams with the management ofclinical trials in a positive and dynamic environment. Working under thedirection of the Research Program Manager key responsibilities for thisposition include:

Core Responsibilities

RegulatoryManagement 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.

Supportand 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.

MinimumHiring Standards:
Demonstrated knowledge of federal regulations as well as protection of human subjects and HIPAA
Must have ability to analyze interpret and implement complex federal state and sponsor regulations
Must be knowledgeable of GCP/ICH guidelines for clinical studies.
Bachelors degree or equivalent experience
At least 2 years of direct Clinical Research Coordinator experience.
2 or more years experience in Clinical Research Regulatory affairs.
Demonstrated understanding of clinical research including all types and funding sources
Maintain CITI credentials for Human Subjects Protection and Good Clinical Practice (GCP)
Excellent oral and written communication skills
Must possess the ability to set priorities make timely decisions and meet deadlines.
Ability to work collaboratively in a large and complex organization.
Comfortability working in and fostering a diverse faculty staff and student environment
Extremely organized and detail-oriented
Strong communications skills attention to detail and time management skills.

Demonstrated ability to work in and foster an environmentof respect professionalism and civility with a population of faculty staffand students from various backgrounds and experiences or a commitment to do soas a staff member at VCU.

Preferred Hiring Standards:
Regulatory management of multi-site studies strongly preferred.
Experience in an academic medical center environment.
Prior experience using OnCore or other clinical trial management systems preferred.
Prior experience using Veeva Site Vault preferred.
Knowledge of VCU and/or VCU Health.
Experience utilizing EPIC (Electronic Medical Record).
Proficient with Microsoft Office Suite.
Active clinical research certification e.g. SOCRA ACRP or ability to obtain certification.

Additional Information:
This is a restricted position with no set end date and continued employment is dependent upon project need availability of funding and performance.

Position will remain open until filled.

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCUs 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: is committed to hiring veterans! VCU will include a veterans period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!

Virginia Commonwealth University is an equal opportunity employer.

Please note that if you are employed as a university employee working in any of the health systems facilities you will need to follow VCU Health System policies which will include but will not be limited to vaccination requirements.

Jewel Jefferson

Required Experience:

Senior IC