Director of IRB Operations & Compliance

SUMMARY : In partnership with the Organizational Official (OO), the Director, IRB Operations & Compliance Director, IRB Operations & Compliance plans, directs, and oversees the IRB operations including policies, objectives, and initiatives to ensure company compliance with federal regulations, ICH / GCP (E6) guidelines, and accreditation standards relating to IRBs, the protection of human subjects, good clinical practice, and company policy and procedures.

The Director, IRB Operations & Compliance is also responsible for providing professional consultation in regulatory guidance and expertise to board members, clients, and administrative staff.

Additionally, provides leadership which exhibits and instills a customer service and quality focused approved for providing service excellence company wide.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

Leadership

Contributes to the development of short- and long-term strategic planning for Salus IRB operations in consultation with the Board of Directors and the OO.

Responsible for evaluating and reporting on progress to plan(s).

• Responsible for maintaining a positive organizational image and positive collaboration with employees, key clients, vendors, and partners.
• Engaging, inspiring, developing, and leading employees to achieve organizational objectives.
• Leads the Leadership Team meeting at least once a quarter. Documents minutes from the meeting and monitors completion of action items.
• Recruits and interviews candidates for hire.
• Evaluates performance for direct reports and causality for employee termination.
• Assists the Organizational Official :
• Provides a high level of oversight of client deliverables and collaborates with business leadership to resolve issues or concerns.

resolves escalated issues brought by clients

notifies the OO of any recurring or escalated issues regarding same

Financial Management

Oversees IRB operations annual budget and provides direction on its purposes and uses.

Board Management

• Serves as the point of contact for board members to address reports of undue influence, concerns or issues related to the IRB member role and / or responsibility, function of the IRB or IRB support staff.
• Reviews meeting minutes to ensure board actions are appropriate and in compliance with company policies and federal regulations.

Collaborates with operations leadership and / or the quality assurance manager to resolve findings in an appropriate manner.

• Oversees the periodic performance evaluation of the IRB chairs, vice chairs and IRB members.
• Determines the training / educational needs of the board members and support staff, including identifying and selecting speakers and topics for the training conference.
• Recruits qualified board members to fulfill appropriate representation on the IRB.

Quality

Identifies and works directly with the quality assurance manager for continuous quality improvement initiatives related to IRB process, compliance, and customer service areas.

Develops and / or reviews and approves Standard Operating Procedures (SOPs) and Procedural Documents.

Regulatory Oversight & Compliance

Stays abreast of FDA, OHRP, and other regulatory changes or implications, and implements procedural changes accordingly.

Considers existing policies, regulations, guidance documents, changes in industry, new research areas, best practices, etc.

that may affect current services, operational procedures, and or expansion of services.

• Plans, directs, and oversees regulatory compliance for the organization and its operational policies to ensure adherence to the federal regulations relating to clinical trials and non-interventional research, IRBs, the protection of human subjects, AAHRPP, and good clinical practices.
• Researches and conducts literature review of often new or complex research designs or proposals to ensure client compliance with applicable regulations and continued company compliance in accepting and reviewing the research.
• May disapprove research approved by the IRB when the approval is not in line with federal regulations or standard operating procedures.
• Provides regulatory and company policy guidance to and serves as a resource for all levels of the organization, including board members, leadership team, support staff, and clients, investigators and other study staff.

Reviews IRB reporting to the federal agencies to ensure proper notification and resolution as well as compliance with standard operating procedures prior to distribution to regulatory authorities.

Performs high level review of oversight incidents for regulatory implications and collaborates with operations leadership and the quality assurance manager to ensure an effective resolution and appropriate documentation.

Hosts Sponsor audits, regulatory inspections, and AAHRPP site-visits; oversees QAU audit responses and follow-up, as needed.

Reviews and approves requests for Planned and Unplanned policy deviations.

• Approves change requests to the operational database and IRB information system to ensure changes do not impact the database function or operations in a way that could have regulatory implications.
• Attends professional conferences for regulatory and training purposes.
• Recruits special expert consultants, as needed.

Qualifications :

To perform in this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.

Education and / or Experience :

• Bachelor’s degree in Business or Health Administration or an equivalent combination of education, training, and directly related work experience.
• Minimum ten years clinical research or IRB administration experience to include project management, operations management, and regulatory compliance.
• Proficient knowledge of federal regulations applicable to clinical trials and non-interventional research, human subjects research and protections and good clinical practices.
• Certified IRB Professional (CIP) is required.

Knowledge, skills and abilities :

Excellent organizational and communication skills

Excellent leadership and interpersonal skills.

Proven ability to prioritize and handle multiple tasks effectively.

Must be self-motivated and detail oriented.

Successfully works independently and in a team environment.

Successfully applies problem solving skills.

Ability to manage complex projects.

Knowledge and application of MS Office and IRB management software, and web-based programs.

Supervisory Responsibilities :

Direct Line Reporting :

Manager, Training and Compliance

Manager, Broad Services

Quality Assurance Manager

Other :

IRB Members (Consultants) Manages IRB membership by recruiting, setting expectations, reviewing performance evaluations and follow-up, incident / oversights review and follow-up, board survey review and follow-up, responding to / resolving IRB member’s concerns, and managing communication and working relationships between IRB members and administrative support team.