Reports To: Director of IRB Operations and Compliance
Status: Exempt
SUMMARY: This primary responsibility of the IRB Supervisor is to provide administrative oversight, coordination and support for the designated IRB staff team. This includes facilitating the review and approval process to ensure compliance with Federal Regulations, ICH Guidelines, Standard Operating Procedures (SOPs), and company policies. This position works closely with the Director of IRB Operations and Compliance and serves as a liaison between Board reviewers and the HRPP by communicating to the Leadership Team any suggestions, concerns, or additional needs of Board reviewers. This position serves as a Non-Scientific Board Member. Additionally, the Supervisor is a member of the Leadership Team and exhibits customer-centered and quality-focused approach and promotes client loyalty by providing excellent customer service in the administration of the board reviewers (internal client) and in working with clients (external client).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Team Leadership:
Lead the designated IRB staff team to meet Salus’ expectation for quality, productivity and goal accomplishment; encourage IRB staff contribution and provide feedback.
Supervise and train direct report(s) to provide administrative and regulatory support to clients and reviewers in accordance with company’s policies and procedures.
Ensure direct report(s) assess research protocols for completeness, accuracy, and level of review according to applicable regulation and/or institutional policy in an efficient manner.
Lead employees to encourage maximum performance, service excellence, and dedication.
Participate in quarterly (and ad hoc) Leadership Team meetings.
Identify and interview potential candidates for new hire.
Assess and identify the training needs of staff, reviewers, and clients, as needed.
Contribute to the evaluation of employee performance, as needed and annually.
Assist with new employee training.
Assist in the onboarding of new employees.
Work with Leadership Team and staff to ensure uniformity of review and compliance with IRB policies and applicable regulations.
Maintain awareness of institutional entities, policies, and relationships that affect IRB functioning.
Compliance & Operations:
Ensure compliance with Federal Regulations, ICH Guidelines, and Standard Operating Procedures (SOPs) and company policies.
Provide procedural guidance and advise board reviewers on Salus IRB policy to ensure compliance and adherence to client expectations.
Perform quality review of new study documents inbound and outbound.
Oversee and coordinate activities associated with the review of client submissions within established timelines such as:
Ensuring distribution of submissions among IRB administrative staff for review within established timelines.
Assigning reviewers for new studies, additional investigators, continuing review and all other submissions and coordinate for consultants, when needed.
Ensuring regulatory records are accurate, as specified by Salus IRB policy and procedures, and communicated to clients accordingly.
Coordinate, assess, process and maintain accurate database records and resolutions for: Unanticipated problems, non-compliance, suspensions/terminations, participant inquires, adverse site audit inspections (FDA Form 483, OHRP Determination letters, and Warning Letters).
May assist with processing of client deliverables such as: initial protocols, additional investigators, continuing reviews, protocol amendments, consent form document revisions, recruiting materials, protocol deviations, investigator non-compliance, etc., within the established turnaround time, when needed.
Assists with development of SOPs, administrative procedures and checklists, quality improvement and implementation of new procedures within the organization.
Assists in sponsor and regulatory inspections, as needed.
Client Services:
Communicate effectively with clients, staff members, board members, investigators, and study personnel to identify and resolve issues; notify Director of IRB Operations and Compliance as necessary.
May serve as primary point of contact for clients and responds to client inquiries in a professional and timely manner.
Non-Scientific Board Member Responsibilities:
Serve as a member working directly with IRB members, sponsors, investigators and study personnel.
Ensure that research approved by expedited procedure are presented to the board per federal regulations and Salus IRB policy.
Recommend revisions to study documents as necessary for clarity, accuracy, and compliance with federal regulations and Salus IRB policy.
Review assigned research material and complete the associated Reviewer Summaries.
Other:
May attend training webinars and/or conferences.
Other duties may be assigned 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:
BA/BS degree preferred.
At least five years’ experience in IRB or clinical research environment preferred. Will consider other industry or related experience.
At least three years’ experience as an IRB Coordinator preferred.
Working knowledge and interpretation of all IRB-related regulations preferred.
KNOWLEDGE, SKILLS AND ABILITIES:
Excellent organizational and communication skills.
Strong interpersonal skills with demonstrated ability to interact appropriately with positive attitude, including good judgment, high personal standards of work, able to initiate action and motivate others.
Ability to prepare and present presentations (training, process-related).
Proven ability to prioritize and handle multiple projects effectively, including reacting promptly to a large variety of requests and needs, sometimes in stressful situations.
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 Word. Knowledge of MS Access and other web-based programs preferred.
To perform the job successfully, an individual should demonstrate the following competencies:
Customer/Client service (internal/external) – Manages difficult or stressful client situations; responds promptly to client needs, solicits client feedback to improve service; responds to requests for service and assistance.
Organization – Prioritizes and plans work activities and uses time efficiently; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
Analytical – Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to compliment data; designs work flows and procedures.
Language Ability – Possesses the ability to read, analyze, and interpret general business documents, SOPs, professional journals, technical procedures, and IRB-related regulations; writes SOPs and business correspondence independently; speaks effectively before groups and presents information and ideas clearly; responds concisely and efficiently to questions from clients, IRB members, investigators, study personnel, auditors, staff, etc.
Reasoning Ability – Solves practical problems and deals with a variety of concrete variables while maintaining compliance with applicable regulations/requirements and SOPs; interprets a variety of instructions furnished in written, oral, or diagram form.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
Technical Skills – Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.
As an AAHRPP-accredited, unbiased, non-profit IRB, Salus IRB is committed to upholding the highest standards in human research protection while providing the same high level of service and expertise that our customers have relied on for more than 35 years.
Salus IRB employs a consultative partnership approach when working with sponsors and investigators, providing added value by delivering IRB services in a convenient, reliable and efficient manner.