Director, Clinical Research-Muscular Dystrophy Translational Research - School of

Summary

This position would serve as the research associate director for the Translational
Research Program in Muscular Dystrophy. In this role, the individual will oversee multicenter consortium
studies, clinical research operations, regulatory operations, and quality assurance. Under the direction
of the Center Director, this team member will collaborate with all members of the clinical research team
to ensure that multisite studies are set up in a compliant manner, that research oversight occurs
appropriately, that all regulatory requirements are followed, that research objectives are met, and that
ethical obligations are kept. Key responsibilities include:
 Demonstrated understanding of clinical research management duties from study initiation to
close‐out.
 Demonstrated experience and expertise in clinical research operations at multisite trials.
Oversee the team responsible for carrying out network studies.
 Demonstrated expertise in regulatory guidelines, including IRB requirements, Human Subjects
protection regulations, and all aspects of IRB approved protocols. Provide oversight and
guidance for the regulatory team.
 This individual will collaborate with the business operations team to ensure that regulatory and
compliance practices are at the forefront of business operations.
 This individual will work with the business operations team to develop and implement robust
reporting tools for analysis of program and network operations to measure performance.

Typical Duties

(10%): Site Level Regulatory Guidance
o Manage the Regulatory team priorities, including: 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.
o Manage regulatory team submission timelines and follow up
o Ensure compliance with federal, local and institutional regulations through ongoing
communications with VCU Office of Human Subjects Protection and all applicable entities
o Oversee Auditing and Monitoring activities as indicated
o Create and manage quality assurance systems to ensure accurate and high quality data
collection practices

(40%): Network Project Management
o Provide overall support for rare disease research network including managing sites across
network, providing site training on protocols, and coordination across multiple trials in the
network
o Tracking across all trials, reporting to industry and foundation partners
o Make determinations on site capability

(40%): Protocol/Network Regulatory and Compliance Requirements
o Manage multisite trial protocols, including protocol development, amendment
development and annual reviews
o Ensure compliance with the international, federal, local and institutional regulations as
applicable to multisite trials
o Create documents and process for Initial submissions, Amendment Revisions, Annual
Reviews, Staff changes, Protocol deviations/violations, Serious Adverse Events (SAEs),
Unanticipated Problems (UPs), Sponsor Safety Reports, Corrective Action Plans, others as
applicable for each trial.
o Oversee Auditing and Monitoring activities as indicated
o Create and manage quality assurance systems to ensure accurate and high quality data
collection practices
o Participate in Auditing and Monitoring activities as indicated
o Manage all audit and monitor findings and responses as required
o Participate in quality assurance systems to ensure accurate and high quality data collection
practices

(10%): Program Level Management
o In conjunction with Center Director and Director of Business Operations, this individual
will be responsible for strategic direction and day to day operations of the program
o Oversee the regulatory team and network team directly, which is currently made up of 5
direct reports.
o Implement compliant policies and procedures across all direct reports

Essential Qualifications

 Bachelor’s Degree or equivalent related 5+ years of experience
 Clinical Research Coordinator certification required (CCRC, CCRP, CCRA)
 Several years of progressively responsible work experience
 Several years of high level regulatory and/or project management experience
 Must be able to complete mandatory competencies and certifications required by VCU and the NIH
Human Subject Protection training required by federal regulations for research
 Experience managing multisite clinical research studies
 High level communication skills, written and verbal
 Demonstrated experience working in and fostering a diverse faculty, staff, and student environment
or commitment to do so as a staff member at VCU.

Preferred Qualifications

 Experience in human subjects research with participants with neurological disorders
 Familiarity with IND submissions
 Experience with study management
 Familiarity with laboratory research and drug development pathways
 7+ years of high level regulatory and/or project management experience

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/

Virginia Commonwealth University is an equal opportunity, affirmative action university providing access to education and employment without regard to race, color, religion, national origin, age, sex, political affiliation, veteran status, genetic information, sexual orientation, gender identity, gender expression, or disability.

This position is open until filled.

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

ORP Eligible: Yes

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.

UNIVERSITY JOB CODE: Asst Director RS 1-3

Salary Range: Commensurate with experience



Position Details:

Department: Neurology / 1590
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE: 100
Exemption Status: Exempt



Contact Information:

Contact Name: Denise Mitchell

Contact Email: denise.mitchell1@vcuhealth.org

Contact Phone: