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 VCU’s generous benefits package that includes: competitive health benefits, paid annual and holiday leave, retirement planning and savings options, tax-deferred annuity and cash match programs, Virginia Retirement System (VRS), professional development & certifications, tuition waiver, parental leave, caregiving leave and community service leave. Learn more about VCU’s benefits here: https://hr.vcu.edu/careers-at-vcu/why-work-at-vcu/

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.

Position Summary:

This position would serve as the genetic counselor for the Translational Research Program in Muscular Dystrophy. This program is responsible for developing disease modifying and other innovative therapies for individuals with muscular dystrophy. In this role, the incumbent works with a group that leads an international network aimed at achieving this objective.

For all clinical research studies assigned, the Genetic Counselor is responsible for conducting clinical research activities in a compliant and efficient manner from study initiation to close out. Under the direction of the Principal Investigator (PI), collaborates with all members of the clinical research team to ensure all federal, state, university and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept. Core responsibilities are listed below along with other tasks and duties as assigned.

Core Responsibilities:

(30%): Genetic Counseling

• Provide genetic counseling for families primarily in neuromuscular Genetics from a broad range of socioeconomic, educational, cultural, and ethnic backgrounds
• Assist families obtaining access to resources for rare genetic conditions
• Analyze personal and family histories for the presence of genetic conditions.
• Perform individual

(20%): Regulatory and Compliance Requirements

• Understand and adhere to all human subject protection and IRB regulations required for clinical research.
• Understand duty to report obligations related to research conduct, and the appropriate university channels for reporting concerns
• Participate in meetings with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol and regulatory requirements.
• Coordinate auditing and monitoring activities for assigned studies.

(30%): Data Management

• Assist PI and study team members in the management of study data for new and ongoing clinical research studies assigned
• Maintain study files according to GCP guidelines and in audit ready condition
• For assigned studies, ensure subject data is entered into sponsor case report forms, databases and VCU systems in a timely manner and in accordance with sponsor and university.
• Review and respond to all queries within required time frames, seeking input from PI’s and other study staff as appropriate.

(20%): Clinical Skills

• Complete VCUHS orientation and training modules as required for the department and clinical research projects
• Conduct applicable clinical activities only as approved and required for each clinical research project
• All clinical skills must be conducted in VCUHS approved clinical areas only. Any protocol required clinical skill requires current VCUHS competency verification/documentation prior to performing each activity
• Must maintain all required VCU and VCUHS competencies related to performing research related clinical skills.
• Cannot perform any tasks that by state or local law require a license to perform, unless such license is on file and approved by VCU and VCUHS

Minimum Hiring Standards:

• Master’s Degree or equivalent related 5+ years experience
• Appropriate licensure and/or board certification
• Highly competent with computer software, including database, spreadsheet and word processing applications
• 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 in participants with neurological disorders
• Familiarity with eTMF software, RedCap, RedCap Cloud and/or other EDC
• Experience administering validated survey instruments

UNIVERSITY JOB CODE: Sr. Clinical Research Coordinator 1-3 (34114-34116)

Position will remain open until filled.

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.

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