IRB Coordinator

Position Title: IRB Coordinator Reports To: IRB Manager Status: Non-Exempt Remote Position but must reside in TX, WI, OH, IL, IN, MD, MI, MO SUMMARY: Under the direction and guidance of the IRB Manager, this position provides administrative support to the Manager, IRB members, clients, investigators, and study personnel. ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned as needed.

• Ensures compliance with Federal Regulations, ICH Guidelines, Standard Operating Procedures (SOPs), and company policies
• Provides procedural guidance to board members, team members and clients
• Coordinates activities associated with the planning, facilitating, and follow-up of convened IRB meetings, IRB action items and expedited review items such as:
• Processing of: initial protocol, new investigators, continuing review, protocol amendments, consent form document revisions, recruiting materials, protocol deviations, investigator non-compliance, etc., within the established turnaround time
• Attends and facilities multiple weekly IRB meetings
• Actively participates in the Board meeting to ensure Board review and discussion of all agenda items and ensures the meeting minutes are accurately recorded, as specified by Salus IRB policy and procedures
• Reviews study documents submitted for IRB review and completes appropriate checklists
• May assist with day-to-day expedited review requests from clients such as minor ICD revisions and recruiting/study materials
• Communicates effectively with clients, staff members, board members, investigators, and study personnel to identify and resolve issues, responding to inquiries in a professional and timely manner
• Prepares and finalizes IRB meeting agendas and minutes, and ensures action items are processed and communicated to the client accordingly
• Ensures all agenda items requiring follow-up are appropriately documented on the meeting minutes and are followed through to resolution within the established timeline
• Tracks and maintains IRB submissions in the database
• Ensures all study documents are filed in a timely manner and study files are maintained in accordance with company policy
• May coordinate study document translations working directly with the vendor
• Performs data entry, photocopying, scanning or posting documents to GlobeSync, the web-based document distribution system
• May assist in training of new employees
• May attend educational conferences

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: 1. BA/BS degree preferred 2. At least two years experience supporting IRB activities or clinical trials experience preferred. Will consider other industry or related experience 3. Working knowledge and interpretation of all IRB-related regulations preferred 4. Industry certification or willing/able to obtain certification within one year of hire is preferred KNOWLEDGE, SKILLS AND ABILITIES: 1. Excellent organizational and oral/written communication skills 2. Detail oriented; ability to provide accurate client deliverables in a fast-paced, deadline driven environment 3. Must be self-motivated with proven ability to prioritize and handle multiple tasks effectively and accurately 4. Ability to establish priorities and respond promptly to a large variety of requests and needs, in a fast-paced and deadline driven environment 5. Successfully works independently and within a team 6. Successfully applies problem solving and critical thinking skills 7. Knowledge and application of MS Office Suite and other web-based programs To perform the job successfully, an individual should demonstrate the following competencies: Customer/Client service – 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; assists in setting goals and objectives. Language ability – Ability to read, analyze, and interpret general business documents, SOPs, regulatory documents, technical procedures, and IRB-related; writes business correspondence independently; speaks effectively and presents information and ideas clearly; responds concisely and efficiently to questions. SUPERVISORY RESPONSIBILITIES: None. Apply tot his job Apply To this Job