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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: https://hr.vcu.edu/current-employees/benefits/university-and-academic-professional-benefits/

Unit: School Of Medicine MBU

Department: Neurology

Department Summary: The Department of Neurology has a talented, robust team of faculty and staff members spanning nine divisions including representatives from every neurology subspecialty in adult and child neurology, plus award-winning educators, clinical and translational neuroscientists and master clinicians.

Duties & Responsibilities:

This position serves as consortium administrator for the Center for Inherited Myology Research. In this role the individual is required to provide strategic management and oversite across international multicenter consortium studies. Under the direction of the Principal Investigator (PI), this position will collaborate with all members of the consortium study teams as well as external stakeholders and funders to ensure all federal, state, university, and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept. Good oral and written communication skills are essential.

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

This posting is for two positions.

Core Responsibilities:

• Consortium Coordination - 40%
  • Site management for international multi-center consortium. Manages projects on a global scale; including study start up for each site, organization of site staff training and tracking of delegation logs and other documentation to ensure compliance with study protocols, regulatory agencies and multiple funding contracts. Monitors the readiness of sites, their performance and data submissions. Acts as a liaison between sites and study investigator and functional leads. Ensures adherence to ICH-GCP guidelines as well as FDA guidelines.
  • Organization and participation of international meetings for training and data presentation. Develops training for the study team to ensure protocol and functional assessment training occurs annually as required per NIH / FDA grants.
  • Development and tracking of consortium site metrics to ensure performance is in line with overall study objectives and milestones; including regular checks in with sites for necessary feedback, this includes making recommendations to primary PI for which sites should be included in various studies; and also which sites need to be removed for poor performance. Track sub sites patient enrollments, manage transfer of patient data and materials. Ensure compliance with study protocols and grant funding agencies. Reviews site documents and source data to ensure patient safety, data integrity and compliance
  • Develop and track key performance indicators (KPI) related to site performance
  • Manages communication with external stakeholders/funders, hold monthly meetings and provide progress reports
  • Coordinates with Patient advocacy groups both in the US and globally. Attends conferences and represents the consortium
  • Maintain study documents according to GCP guidelines and in audit ready condition
  • Train and support coordinators at consortium sites to ensure compliance with the protocol and regulatory requirements
• Regulatory and Compliance Requirements - 30%
  • Manage reporting all required information to Regulatory team, includes, but not limited to: Initial submissions, Amendments/Revisions, Annual reviews, Staff changes, Protocol deviations/violations, Serious Adverse Events (SAEs), Unanticipated Problems (UPs), Sponsor Safety Reports, Corrective Action Plans, others as applicable
  • Participate in Auditing and Monitoring activities as indicated
  • Manage all audit and monitor findings and responses as required
  • Ensure compliance with federal, local and institutional regulations through ongoing communication with VCU Office of Human Subjects Protection and all applicable entities
• Data Management - 30%
  • Disseminate data cuts to key stakeholders/funders
  • Responsible for coordination and supervision of the completion of source documents
  • Manage Case Report Form and Query response data
  • Manage subject data entry that supports accurate billing, including EPIC data entry, entering data in a timely manner and reviewing data and clinical invoices with fiscal personnel as necessary to ensure accuracy and completeness of study billed clinical items/procedures and facilitate timely billing of sponsors for research activities

Qualifications:

Minimum Qualifications

• Bachelor’s Degree (public health, health administration, business administration) or 3 – 5 years of relevant professional experience; or equivalent combination of education, training, and experience.
• Five or more years of direct experience conducting clinical research and managing clinical research data while working within IRB, Federal and state regulatory guidelines
• Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.

Preferred Qualifications

• Master’s (public health, health administration, business administration) or Professional Certification such as CCRA (certified clinical research associate), CCRC (certified clinical research coordinator), CCRP certified clinical research professional) or equivalent certification.
• Prior experience in human subjects research in participants with neurological disorders; or rare genetic disease.
• Familiarity with eTMF software, Veeva, RedCap and/or RedCap Cloud and other electronic data capture software.
• Prior experience managing international multicenter consortium studies.

Salary Range: $95,000 - $125,000

Benefits: All full-time university staff are eligible for VCU’s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt

Hours per Week: 40

Restricted Position: Yes

ORP Eligible: Yes

Flexible Work Arrangement: Hybrid

University Job Title: 32911Y - Administrator RS 1

Contact Information:
Contact Name: Eric Hunsley
Contact Email: eric.hunsley@vcuhealth.org