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The Research Regulatory Program Manager provides professional direction and serves as the lead role in the day-to-day operation and oversight of one (or more) of the three primary Regulatory Affairs Committees for Baylor Scott and White Health. These committees include Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC) and Institutional Biosafety Committee (IBC). Directs activities related to maintenance of compliance with Federal, State and local regulations and policies pertaining research involving human subjects and/or involving the human use of animals and/or the use of biological materials and potentially hazardous agents subject to IBC oversight research.
Assumes daily accountability for ensuring compliance and efficiency of committee (IRB/IACUC/IBC) operations Helps to ensure requirements are clearly communicated, negotiated, resolved, and properly documented as required by regulations and policy
Monitors mandatory project reporting to ensure program compliance with Federal Regulations Manages operations of the committee to ensure meetings are appropriately conducted and documented per federal regulations Partners with managers and leadership across the organization to assess and recommends appropriate initiatives for improving committee performance impacting research and serves as a key spokesperson to various committees regarding research and serves as a liaison for web-based system improvements/efficiencies to address research community and committee needs
Provides regulatory analysis of submissions to ensure adequacy of proposed research for review RRA Director/Chair of potential issues with proposed research to mitigate risks in higher risk research and prepares communications to members to facilitate the review process and ensures investigators have provided sufficient information for documenting a regulatory basis for committee decisions Responsible for quality improvement activities relative to committee and support functions to ensure a high quality program.
Responsible for ensuring appropriate orientation/education of committee members and research community to avoid noncompliance with regulations and policy.
Provides advice to investigators regarding regulatory issues and ethical concerns related to research involving human subjects, animals and hazardous materials.
Continually develop, implement, evaluate and improve operational policies and procedures for efficient and effective processing of research protocols Responsible for ensuring increased awareness and accountability of the Committee components of the Regulatory Affairs Division
Prepares reports of IRB/IACUC/IBC activity to ensure leadership is kept informed Responds to internal and external audits relative to IRB/IACUC/IBC activities to ensure any corrective action plans are implemented in a timely manner
Accountable for management of a comprehensive approach to regulatory affairs issues including human subject protections, animal welfare and other regulatory affairs issues) to ensure a consistent and robust approach is maintained at all entities across the system Serves as a liaison between the IRB and Privacy Office to ensure compliance with privacy regulations in human subject research
Participates as a voting member of the IRB Serves as an experienced designee of the IRB Chairman for designating projects as meeting the regulatory requirements for exemption from further oversight Serves as an experienced designee of the IRB Chairman for providing expedited initial and continuing review approvals
Participates in evaluation of research proposals at full board meetings Has signature authority for internal and external communications relative to IRB actions Assists the Director with Management of Federal Assurances (OLAW, OHRP, NIH) and Committee Registrations as necessary
Performs other position appropriate duties as required in a competent, professional and courteous manner
The information contained in this job description is intended to describe the essential job functions required of those assigned to this job.
It is not intended to be an exhaustive list of all responsibilities, duties, knowledge, skills, and abilities needed to perform the job.
Please note that management retains the right to assign or reassign duties and responsibilities to this job at any time. The ability to competently perform all the essential duties of the position, with or without reasonable accommodation, demonstrated commitment to effective customer service delivery, integrity, and the ability to work productively as a member of a team or work group are basic requirements of all positions at Baylor Scott & White Health KNOWLEDGE, SKILLS AND
Sound knowledge of regulations and policies governing the ethical conduct of clinical research Advanced analytical, interpersonal and organizational communication skills
Proactive individual that functions independently and is comfortable working under extreme deadlines
Excellent problem solving skills to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations
Ability to handle proprietary and confidential information with appropriate discretion
Sound judgment and decision making
Possesses the ability to analyze complex problems, interpret operational needs and develop integrated creative solutions
Communicates openly and in a timely way.
Listens to understand. Speaks and writes clearly.
Shares information appropriately. Keeps others well informed. Encourages others to share contrary views.
Responds in a timely manner to messages/requests Adaptability/Flexibility
Deals effectively with change and uncertainty.
Copes well with stress and pressure. Is patient.
Maintains a positive outlook.
Deals constructively with mistakes and setbacks.
Looks for ways to help the organization
Works together to achieve successful outcomes. Seeks input from others.
Seeks win-win solutions.
Supports a shared purpose.
Builds relationships. Supports others to achieve success.
Knows when to compromise and find mutually acceptable solutions
EDUCATION - Bachelor's
EXPERIENCE - A minimum of 2 years experience required
Baylor Scott & White Health (BSWH) is the largest not-for-profit health care system in Texas and one of the largest in the United States. With a commitment to and a track record of innovation, collaboration, integrity and compassion for the patient, BSWH stands to be one of the nation’s exemplary health care organizations. Our mission is to serve all people by providing personalized health and wellness through exemplary care, education and research as a Christian ministry of healing. Joining our team is not just accepting a job, it’s accepting a calling!