Director, Clinical Research Office, School of Medicine

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Position Summary:

**Sr. Administrative Leadership Opportunity - Clinical Research** Virginia Commonwealth University School of Medicine (SOM) is seeking an experienced senior level clinical research management professional to serve as the Director for the School of Medicine Clinical Research Office (SOM CRO). This position will be responsible for leading the SOM CRO staff in building and maintaining the necessary clinical research infrastructure to support clinical research operations and financial management, facilitate decision-making, and improve process efficiency to allow for continued growth of clinical research in the School of Medicine. This position reports directly to the Assistant Dean for Research Administration and will work closely on shared initiatives with the Assistant Dean for Acute Care Research & Clinical Trials. Success will require strong collaboration with research leaders across SOM, its departments and affiliated centers, as well as university and VCU Health System research offices.

This position is focused on operational, financial, and administrative oversight of clinical research conducted in the VCU SOM. The SOM CRO specializes in supporting clinical research throughout SOM with key areas of focus that include:

• Supporting efficient study activation; directly overseeing administrative study activation in OnCore, coverage analysis, and budget development and negotiation.
• Managing the Clinical Trial Collaborative, a Clinical Research Coordinator (CRC) shared/pooled resource supporting SOM Investigators.
• Maintaining CRC training programs for onboarding and continuous educational needs.
• Managing clinical research revenue recovery and clinical research billing, utilizing the OnCore Financial Console.
• Developing and maintaining reporting and analytics to support data driven decision making at school and department levels for resource allocation, staffing, and program management.

Primary Responsibilities:

The Director of the SOM CRO key areas of responsibility and focus will include:

• Oversight of day to day operations of SOM CRO; including direct management of 3+ direct reports.
• Oversight of the overall SOM clinical research workflow; coordination and collaboration with various research offices and stakeholders to ensure proper alignment of research processes, resolve bottlenecks, and strengthen efficiency in activation and study management.
• Advise and collaborate with SOM research leadership to establish the vision, strategic goals, and priorities for SOM CRO.Lead implementation of approved plans.
• Develop and maintain operational standards and metrics to continuously monitor progress for all major SOM CRO functions and strategic initiatives/goals.
• Maintain documented school-level operational policies, procedures, and processes that support compliant, efficient, and quality clinical research.
• Represent SOM and serve as key contributor in university and school-level committees and initiatives to improve clinical research administration and operations.
• Actively participate as a key stakeholder in systems integrations or enhancement projects related to clinical research, such as EPIC/OnCore billing plan integration, IRB or regulatory software, support implementation of advanced technology for clinical research, etc. Advocate for SOM needs.
• Continuously evaluate infrastructure and resources at department, school, and university levels; identify program gaps and areas of risk, make recommendations to leadership for improvements to policy, process, staffing, training, reporting, etc to mitigate risk.
• Ensure the SOM CRO has effective communication strategies to disseminate information to all SOM Study teams and stakeholders as appropriate.
• Stay current on all institutional, state, and federal regulations and regulatory requirements to ensure SOM maintains compliance.
• Collaborate directly with SOM Office of Research Administration to facilitate training and efficient transition of clinical studies from pre-award activation to post award management.

Minimum Hiring Standards:

• Bachelor's degree and 10+ years of experience in clinical research.
• At least 5 years of progressively responsible experience in clinical research management; with prior experience managing university based clinical research programs, multi-center clinical trials
• Must have prior experience directly supervising research staff.
• Demonstrated experience in business planning, financial analysis, and/or strategic planning.
• Demonstrated ability to lead in an environment of rapid change.
  Demonstrated experience with human subject research; Good Clinical Practice, FDA and DHHS regulations as well as ICH E6.
• Thorough level of understanding of both clinical trial coordination and administration in areas such as: feasibility assessment, coverage analysis, budget development/negotiation, clinical research billing, regulatory management, study conduct, and data management.
• Must be proactive, resourceful, self-motivated, exercise independent judgement, have strong analytical and problem-solving skills.
• Must be dedicated to leading a staff that provide high levels of customer service while managing multiple projects in a fast paced, deadline driven environment.
• Must possess exemplary interpersonal skills to interact professionally with personnel at all levels in the organization.
• Must have a demonstrated commitment to fostering diversity and inclusion in past experiences or a commitment to do so as a staff member at VCU.

Preferred Hiring Standards:

• RN and/or Master's degree such as MHA, MBA, MPH or scientific field.
• Nationally recognized certification in clinical research management, i.e., ACRP or SOCRA.
• Significant clinical research leadership experience.
• Strongly prefer significant prior experience utilizing OnCore clinical trial management system, including the Oncore Financial Console; and experience with OnCore integration with EPIC or other electronic medical record software.
• Significant experience working in a large academic medical center environment.

This position is eligible for hybrid telework .

Position will remain open until filled. Review of applications will begin the week of October 16th with priority given to applications received before 10/16/23.

The School of Medicine continuously strives for our workplace and learning environment to reflect the demographic and social milieu of the communities we serve. All qualified applicants are encouraged to apply.

VCU is committed to hiring veterans! VCU will include a veteran's period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!