Associate Director for Clinical Research Administration & Operations - Sch. of Medicine, Dean's Ofc

**Administrative Leadership Opportunity – Clinical Research** Virginia Commonwealth University School of Medicine (VCU SOM) is seeking an experienced clinical research management professional to serve as the Associate Director for Clinical Research Administration and Operations in the School of Medicine Office of Research Administration. This key administrative leadership position is essential to support clinical faculty in a diverse and growing clinical research portfolio in the VCU SOM. This position is focused on administrative, financial, regulatory, and operational oversight of clinical research conducted in the VCU SOM. The Associate Director for Clinical Research Administration and Operations is responsible for ensuring VCU SOM has efficient and effective administrative processes and infrastructure in place to support: efficient study activation, compliant study conduct, financial feasibility, data management, and reporting.
Areas of responsibility and focus will include:
Represent SOM and serve as key contributor in university and school-level committees or initiatives to improve clinical research administration and operations. Seek input from appropriate stakeholders; advocate and make recommendations to leadership for improvements to policy, process, staffing, training, reporting, etc.
Resource Needs: Analyze infrastructure and resources in place at department, school, and university levels that support clinical research and recommend improvements that support strategic growth of SOM’s clinical research portfolio. Recommend staffing models for clinical research coordination and management within SOM.
Monitoring and Reporting: Develop, implement, and maintain a school-wide reporting program for clinical research operations management. Develop reporting and analytics to aid the school, departments, and study teams in evaluation of clinical research activity aimed at increasing productivity and improving data quality to enhance study management, resource allocation, and decision making.
Continually improve upon and maintain SOM administrative activation and amendment processes – monitor effectiveness, timelines, and make improvements where needed. Develop, maintain, and routinely report on standardized activation metrics at both school and department/division levels.
Oversee approval process for all SOM clinical studies being activated in OnCore, VCU’s clinical research management system. Ensure compliance requirements are met and documented.
Clinical Research staffing, onboarding, and training: Develop and maintain a central clinical coordinator pool to support various SOM units in need of fluctuating coordinator or regulatory support.Develop and implement standard school-wide onboarding and training processes for new clinical research team members.
Oversee SOM Coverage Analysis and Budget Development Processes: Direct a team responsible for ensuring completion of coverage analysis, budget development, and budget negotiation for all applicable clinical studies.
Quality Control/ Quality Assurance (QC/QA):Assemble and lead a steering committee to drive consistent standards school-wide. Oversee the development and implementation of QC/QA processes for clinical research coordination and management (e.g., regulatory, subject data) to ensure consistency in review parameters and reporting outcomes across departments/divisions in SOM. Ensure appropriate staffing to carry out meaningful review and reporting.
OnCore Study Management: Collaborate with VCU OnCore office and VCU Health System Clinical Research office to ensure our clinical trial management system meets study management, financial management, and data sharing needs.

Minimum Hiring Standards:

Required background: Bachelor’s degree in healthcare or business-related field with at least 8 years of progressively responsible experience in clinical research management. Must possess a thorough 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. Prior experience supervising others is required. Required Skills: Ability to exercise independent judgement in decision making, program management, and interpretation of complex rules and regulations. Must possess excellent written and oral communication skills, time management, 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. Ability to work in a diverse environment required.

Preferred Hiring Standards:

Strongly prefer: Master’s degree or other advanced degree; Nationally recognized certification in clinical research management, i.e., ACRP or SOCRA certification; extensive clinical research leadership experience, prior experience utilizing the OnCore clinical trials management system.

University Job code: Assoc Director 1-3

ORP Eligible: Yes

Position will remain open until filled with a priority application date of May 15th, 2022.

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/

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.

Salary Range: Commensurate with experience



Position Details:

Department: School of Medicine, Dean's Office
Employment Type: UF - University Employee FT
Restricted Status: No
FTE: 100
Exemption Status: Exempt



Contact Information:

Contact Name: Ann-marie Taranto

Contact Email: ann-marie.taranto@vcuhealth.org