Program Manager for Research Compliance and Regulatory Affairs/Pauley Heart Center

Employer
Virginia Commonwealth University
Location
Virginia, United States
Salary
Salary Not Specified
Posted Date
Jun 21, 2022


Program Manager for Research Compliance and Regulatory Affairs

Internal Medicine/Division of Cardiology/Pauley Heart Center

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. VCU School of Medicine comprises 18 clinical departments, eight basic health science departments, and 11 affiliated institutes and centers, and provides preeminent education to physicians and scientists in order to improve the quality of healthcare for humanity. 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/

Summary:

Position #:573940
Acts as program manager for research compliance and regulatory affairs within the Pauley Heart Center and the Division of Cardiology. Supports, collaborates, provides training, consultation, and leadership for researchers and their teams to comply with sponsored, investigator-sponsor, local, state, and federal requirements. Provides guidance, education, recommendations, and support for the nuanced regulations inherent to the varying studies and trials conducted by investigators within the division of cardiology


Major Job Functions:


Research Regulatory Management
  • Completes and/or supports Pauley Heart Center and Cardiology Divisional research staff with the development and submission of documents to applicable regulatory agencies from study start up through completion (local and central IRBs, varying local committees, FDA, etc.)
  • Researches and provides best applicable regulatory pathways for investigator-initiated drug and device trials.
    Provides support for and/or develop essential trial documents as needed for investigator-initiated trials (protocols, ICFs, scripts, DCFs, logs, AEs, etc.).
  • Works with Center and Divisional administrators to develop and execute most effective workflow practices for regulatory over-site and research management.
Research Compliance Management
  • Develops processes for and maintain oversight of Divisional research records management, adhering to all applicable institutional, state and federal laws, regulations, policies, and guidelines and keeping in compliance with any contractual obligations to sponsors
  • Develops Divisional records management SOPs and guidance documents for research staff and faculty. Educates Divisional research staff and faculty of the importance of records compliance at all stages of research, from start up through completion and maintain frequent communication with these teams to ensure ongoing compliance
  • Keeps Divisional research staff and faculty informed of deadlines for records management set forth by the Division and Institution.
  • Acts as a resource for other divisions within DOIM.
Required Education and Experience
  • Knowledge of research development, execution, and administration
  • Exercises independent judgment and critical-thinking skills
  • Excellent written, oral and interpersonal communication skills
  • Ability to manage research personnel
  • Meticulous attention to detail for comprehension of nuanced regulations
  • Ability to manage multiple projects, multi-task and prioritize autonomous
  • Able to work in a fast paced, demanding environment and adapt to changing client status, regulations and work environment
  • Demonstrated knowledge of medical terminology
  • Demonstrated proficiency with multiple computer applications, including but not limited to: MS Word, MS Excel, spreadsheet management, PDF file creation/use, online database use. High level organization skills, accuracy and attention to detail
  • Requires the analytical skill to resolve problems that require the use of basic scientific, mathematical or technical principles.
  • Outstanding verbal and written communication skills, meticulous attention to detail and computer skills including database, word processing and spreadsheet applications
Preferred Education and Experience
  • Advanced degree in relevant scientific field or Allied Health Profession
  • Extensive knowledge of and experience in research regulatory management and study coordination
Job Specific Physical and Cognitive Requirements
Light lifting (less than 20 lb), fast pace, multiple stimulation, intense customer interaction, frequent change, memory, reasoning, hearing, reading, analyzing, logic, standing, bending, and verbal and written communication


Other Related Information


ORP Eligible: Yes

Hours / weeks - 40 hours weekly

Days /hours - Monday - Friday, Generally 8:00 am - 5:00 pm

Position will remain open until adequate applications are received

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

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, education and training



Position Details:

Department: Internal Medicine/Division of Cardiology/Pauley Heart Center
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE: 1
Exemption Status: Exempt




Contact Information:

Contact Name: Brenda Alexander

Contact Email: Brenda.Alexander@vcuhealth.org




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