Reg Compliance/Human Subjects Protection Supervisor

POSITION SUMMARY:

* The supervisor oversees three critical areas of Valley’s Research Department: Regulatory Compliance, Accreditation/Education, and Corporate Compliance. * As a supervisor of Regulatory Compliance, this individual oversees Valley’s relationship with external IRBs from regulatory reviews to reporting requirements. This individual works directly with investigators conducting investigator-initiated research to design and implement non-industry or cooperative research studies. * Manage Accreditation and Education for the Research Department ensuring that Valley is compliant with our current AAHRPP accreditation obligations and that all individuals are educated on the policies and procedures that resulted from this distinction. * Corporate Compliance oversight for the Research Department involves: Research Department’s relationship with Marketing to ensure regulatory compliance of clinical trial marketing; Institution-wide compliance with human subjects protection education (CITI program)

EDUCATION:

Bachelor’s degree in science field, education, public administration, management, or related field required. Master’s degree preferred.

EXPERIENCE:
* Minimum of five years relevant professional experience. Experience working with Institutional Review Boards or human subject’s protection programs or direct experience in a research setting preferred. IRB experience either in a large healthcare system or in an academic medical center. * Demonstrates comprehensive knowledge and understanding of management and administrative principles and practices; an ability to work with committees, manage multiple complex administrative tasks, and prioritize responsibilities. Basic working knowledge of biological principles and scientific methods and basic working knowledge and experience in federal regulations governing human subject research and federal reporting requirements (OHRP, FDA, HIPAA, ICH GCPs, etc.) and AAHRPP accreditation standards. Demonstrated ability to exercise good judgement in areas of ambiguity, discretionary and confidential information and exemplifies high standards of professionalism, responsibility, accountability, and ethical behavior. Ability to function independently and proficiently with minimal oversight drawing upon excellent time management and prioritization skills. Demonstrates exceptional writing and verbal presentation skills.

SPECIAL SKILLS:
Certification as an IRB professional (CIP) is strongly preferred and required within one year of reaching the minimum qualifications.

Area of Talent: Management

Organization: The Valley Hospital

Department: VH RESEARCH – CLINICAL TRIALS

Shift: Day

Full Time

Schedule: 40 hours per week

req14861

United States