Clinical Research Regulatory and Compliance Specialist (in-person)

Clinical Research Regulatory and Compliance Specialist

Baltimore Research and Education Foundation (BREF)

VETERANS AFFAIRS COOPERATIVE STUDIES PROGRAM COORDINATING CENTER, PERRY POINT MARYLAND

(Pay: GS 12)

ABOUT US:

The Baltimore Research and Education Foundation (BREF) is a non-profit corporation that supports the mission of the Veterans Affairs Maryland Healthcare System (VAMHCS) by administrating and facilitating biomedical research and education endeavors. In this capacity, BREF employs research staff and provides other services for conducting clinical research at the Cooperative Studies Program Coordinating Center (CSPCC) in Perry Point, Maryland. The CSPCC executes multicenter clinical trials and other types of research under the Dept of Veterans Affairs (VA) Cooperative Studies Program, as well as trials and research done under agreements with non-VA (external) funders.

GENERAL JOB SUMMARY:

The Clinical Research Regulatory and Compliance Specialist ensures adherence to federal regulations, local policies, and current guidelines governing clinical research. This position plays a critical role in maintaining compliance, protecting human subjects, and supporting high-quality clinical trials within the Department of Veterans Affairs research environment.

JOB DUTIES AND RESPONSIBILITES:

· Evaluate and document compliance with FDA, OHRP, ICH, VA, and CSP regulations and guidelines.

· Review and maintain regulatory submissions and approvals (VA Research and Development Committee, IRBVA Central IRB, FDA.

· Monitor central study files and verify all essential records are present.

· Audit informed consent forms for accuracy and version control.

· Identify and report non-compliance; implement corrective and preventive action plans.

· Develop tools, templates, and processes to ensure regulatory adherence throughout the clinical trial lifecycle.

· Deliver training on regulatory compliance, human subjects protection, and good clinical practices.

· Serve as the regulatory subject matter expert on multidisciplinary clinical trial teams.

· Contribute to risk-based monitoring plans and continuous quality improvement initiatives.

TRAVEL:

· Occasional travel to Baltimore MD or Washington DC as needed, and to other locations to attend center meetings, retreats, and/or center-wide training.

COMPETENCIES

· : treats people with respect; inspires the trust of others; works with integrity and ethically; upholds organizational values

· : Follows BREF policies and procedures; completes administrative tasks correctly and on time; supports BREF goals and values; supports and respects community, diversity, and inclusion.

· : prioritizes and plans work activities; uses time efficiently; plans for additional resources as needed; sets goals and objectives; develops realistic action plans.

· : approaches and interacts with others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments; seeks training and education to improve knowledge and skills.

· : Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.

· : Demonstrates punctuality; follows instruction and responds to supervisory or management direction; takes responsibility for own actions; keeps commitments; commits to work and time necessary to reach goals; completes tasks on-time or notifies supervisor or appropriate person with an alternative plan.

EDUCATION, EXPERIENCE, QUALIFICATIONS

· Must be legally eligible to work in the U.S.

· Employment is contingent upon successful completion of a background check and fingerprinting.

· Bachelor’s degree is required*

· Minimum of 1 year of experience in clinical research regulatory compliance is required*

*Additional education may be substituted for required experience, and additional related experience may be substituted for required education

· Strong knowledge of clinical research regulations (FDA, OHRP, ICH, VA).

· Experience with IRB processes, regulatory submissions, and compliance audits.

· Excellent organizational and communication skills.

· Ability to develop and implement compliance tools and training programs.

WORK ENVIRONMENT AND HOURS

· Work will be performed in-person at the offices of the CSPCC Perry Point MD.

· 40 hours/week, Monday-Friday

· Pay is salary (exempt)

SUPERVISION

: Position reports directly to the CSPCC Associate Center Director of Quality Assurance. In the absence of the Associate Center Director of Quality Assurance, the position reports to the Deputy Director of the VA CSPCC in Perry Point.

EQUAL OPPORTUNITY EMPLOYER

BREF is an equal opportunity employer, thereby ensuring equal opportunity for employment and advancement to all qualified persons without regard to race, color, religion, national origin, sexual preference, lawful political affiliation, marital status, non-disqualifying physical or mental handicap or age.

Salary will be based upon the candidate’s education and training pertinent to the Clinical Research Regulatory and Compliance Specialist duties. Benefits include health care, life and long-term care insurance, a 403(b retirement program, annual and sick leave. If interested in applying for the Clinical Research Regulatory and Compliance Specialist position, please send a cover letter describing your interest in the position and your resume.

Pay: $98,630.00 - $105,206.00 per year

Benefits: