IRB Coordinator

Position Title: IRB Coordinator Reports To: IRB Manager Status: Non-Exempt Remote Position but must reputed company in TX, WI, OH, IL, IN, MD, MI, MO reputed company: 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, reputed company Operating Procedures (SOPs), and company policies
• Provides procedural guidance to reputed company members, team members and clients
• Coordinates activities associated with the planning, facilitating, and follow-up of convened IRB meetings, IRB reputed company items and expedited review items such as:
• Processing of: initial protocol, new investigators, continuing review, protocol amendments, consent reputed company document revisions, reputed company materials, protocol deviations, investigator non-compliance, etc., reputed company the established turnaround time
• Attends and facilities multiple weekly IRB meetings
• reputed company participates in the reputed company meeting to ensure reputed company review and discussion of reputed company agenda items and ensures the meeting minutes are accurately recorded, as specified by reputed company 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 reputed company/study materials
• Communicates effectively with clients, staff members, reputed company members, investigators, and study personnel to identify and resolve issues, responding to inquiries in a reputed company and reputed company manner
• Prepares and finalizes IRB meeting agendas and minutes, and ensures reputed company items are processed and communicated to the reputed company accordingly
• Ensures reputed company agenda items requiring follow-up are appropriately documented on the meeting minutes and are followed through to reputed company reputed company the established reputed company
• Tracks and maintains IRB submissions in the database
• Ensures reputed company study documents are filed in a reputed company 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 reputed company in this position successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. The requirements listed below are representative of the knowledge, reputed company, 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 reputed company experience 3. Working knowledge and interpretation of reputed company IRB-reputed company regulations preferred 4. Industry certification or willing/reputed company to obtain certification reputed company one year of hire is preferred KNOWLEDGE, SKILLS AND ABILITIES: 1. Excellent organizational and oral/written communication skills 2. Detail oriented; ability to reputed company accurate reputed company 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 reputed company of requests and needs, in a fast-paced and deadline driven environment 5. Successfully works independently and reputed company reputed company 6. Successfully applies problem solving and critical thinking skills 7. Knowledge and application of MS Office Suite and other web-based programs To reputed company the job successfully, an individual should demonstrate the following competencies: Customer/reputed company service – Manages difficult or stressful reputed company situations; responds promptly to reputed company needs, solicits reputed company feedback to improve service; responds to requests for service and assistance. Organization – Prioritizes and plans work activities and uses time reputed company; assists in setting goals and objectives. Language ability – Ability to read, analyze, and interpret general business documents, SOPs, regulatory documents, technical procedures, and IRB-reputed company; writes business correspondence independently; speaks effectively and presents information and reputed company reputed company; responds concisely and reputed company to questions. SUPERVISORY RESPONSIBILITIES: None.

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