ID: 7057874 (Ref.No. 311132JC)
Posted: June 14, 2019
Application Deadline: Open Until Filled
Internal Title: Senior Policy Analyst
External Title: Senior Research Compliance Analyst
The Office of Research at Baylor College of Medicine is looking for a Senior Research Compliance Analyst to join the Research Compliance Services (RCS). RCS provides ongoing communication, assessment and reporting services to the Office of Research, investigators and research personnel, as well as multiple institutional oversight committees.
This position is responsible for the provision of verbal and written information and technical applications in support of best practices in meeting regulations and standards for the conduct of human research.
- Reviews standards and all applicable regulation and accreditation standards concerning human research.
- Assures compliance and offers guidance and coordination in regards to regulatory and accrediting bodies.
- Maintains and offers ethical and regulatory guidance in the changing research environment.
- Applies applicable institutional policies and federal, state, and local regulations when regarding the conduct of human research.
- Performs routine and for-cause audits of research to ensure compliance with ethical and regulatory standards
- Attends IRB meetings as a nonvoting member to the IRB as needed to present compliance matters to the IRB.
- Reports audit results to the IRB and works with the IRB to develop Corrective and Preventative action plans for non-compliant issues
- Prepares reports for applicable regulatory bodies on determinations for reportable events
- Works closely with internal audit and or regulatory agencies on routine or for-cause audits
- Conducts educational workshops for all individuals engaged in research at the institution.
- Communicates College policy to departmental personnel, responds to research compliance questions and concerns.
- Develops internal procedures to ensure compliance with policy.
- Plans and organizes a variety of projects directly related to the departmental goals.
- Works with team members to ensure completion of mutual performance goals.
- Bachelor's degree in a related field
- Five years of relevant experience
- Excellent written and verbal communication skills; ability to respond promptly and accurately to customers' inquiries and requests for information
- Strong project management skills
- Ability to initiate and complete tasks with minimal supervision
- Master's degree in a related field
- Five years of experience in biomedical research compliance, research, patient relations, health care, medical/academic setting, or communications
- Knowledge of FDA and IRB regulations, as well as funding and grant compliance pertaining to clinical trial research