Senior Research Compliance Specialist, Reliance

CHOC • Irvine, CA

8d

About The Position

The Senior Research Compliance Specialist (Sr. RCS) functions independently and is responsible for performance of all core Research Compliance activities as assigned. Research Compliance activities include administrative functions for human subjects protection (IRB), animal welfare (IACUC), conflict of interest (COI) institutional biosafety (IBC), stem cell oversight (hSCRO), and research misconduct. Administrative functions includes but is not limited to reviewing submission to the proper review board, scheduling review board meetings, issuing review board determinations, maintaining documentation in accordance with applicable policies, procedures, and regulations, and providing support and guidance to researchers and board members. As a senior member of the Research Compliance team, the Sr. RCC serves as a mentor, an educator, and an informal leader. The Sr. RCC is expected to educate and mentor research team members, facilitate problem-solving and conflict resolution, and may be requested to coordinate special projects. The Sr. RCS is the most senior, non-supervisory, position in the Research Compliance Specialist series.

Requirements

• Minimum four (4) years of experience in research compliance .
• Bachelor’s degree from an accredited college/university.
• CITI Program Training
• Solid knowledge of applicable Federal and state research regulations on human subjects’ regulations, laboratory animal welfare regulations, institutional biosafety regulations, stem cell research regulations, conflict of interest regulations, and research misconduct regulations.
• Able to read; write and speak with professional quality; use computer and software programs necessary to the position, e.g., Word, Excel, Power Point, Access; operate/troubleshoot basic office equipment required for the position.
• Able to relate and communicate positively, effectively, and professionally with others; provide leadership; be assertive and consistent in enforcing policies; work calmly and respond courteously when under pressure; lead, supervise, teach, and collaborate; accept direction.
• Able to communicate effectively in person, in writing, and on the telephone; think critically; work independently; perform basic math and statistical functions; manage multiple assignments; compose written material; work well under pressure; problem solve; organize and prioritize workload; recall information with accuracy; pay close attention to detail.

Nice To Haves

• Minimum of one (1) year research compliance experience in a hospital and/or pediatric research setting.
• Advanced degree in a relevant field.
• Additional training in human and animal subject protection, research conflicts of interest, biosafety compliance, stem cell research oversight, allegations of research misconduct the protection of human subjects in research, humane care and use of animals, conflict of interest policies, research integrity, biosafety compliance, and stem cell oversight.
• Certified IRB Professional (CIP), Certified Professional in IACUC Administration (CPIA), Certified Healthcare Research Professional (CHRC).
• Working knowledge of research compliance and regulatory issues.
• Working knowledge of electronic research compliance submission and review systems.
• Working knowledge of tracking and reporting performance metrics.

Responsibilities

• Research Compliance activities include administrative functions for human subjects protection (IRB), animal welfare (IACUC), conflict of interest (COI) institutional biosafety (IBC), stem cell oversight (hSCRO), and research misconduct.
• Administrative functions includes but is not limited to reviewing submission to the proper review board, scheduling review board meetings, issuing review board determinations, maintaining documentation in accordance with applicable policies, procedures, and regulations, and providing support and guidance to researchers and board members.
• As a senior member of the Research Compliance team, the Sr. RCC serves as a mentor, an educator, and an informal leader.
• The Sr. RCC is expected to educate and mentor research team members, facilitate problem-solving and conflict resolution, and may be requested to coordinate special projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees