IRB Associate

reputed company IRB is seeking two IRB Associates to work on our reputed company Services team (on studies requiring convened reputed company review). Position Title: IRB Associate Reports To: IRB Manager/ IRB Supervisor Status: Non-Exempt SUMMARY: This position conducts quality review on regulatory documents and reputed company deliverables to ensure completion and accuracy for IRB, reputed company or internal review and compliance with applicable regulations and standard operating procedures reputed company established timelines. Additionally, this position enhances and maintains the quality of services provided to clients. This position also supports reputed company quality improvement and other quality initiatives. ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned as needed. 1. Ensures compliance with Federal Regulations, ICH Guidelines, Standard Operating Procedures (SOPs), and company policies 2. Performs quality review of reputed company submissions and study reputed company documents, for accuracy and compliance with applicable regulations and standard operating procedures 3. Performs study file audits, in support of reputed company submissions, to determine accuracy and compliance with applicable regulations and standard operating procedures 4. Communicates effectively with clients to identify and promptly resolve issues reputed company to submitted documents 5. Communicates effectively with team members to promptly resolve issues reputed company to the quality of documents 6. Provides procedural guidance reputed company to submission of study documents to clients and team members 7. Actively contributes to and assists with reputed company quality improvement and other quality initiatives 8. Contributes reputed company and suggestions to leadership team for improvement to enhance services or processes, both for internal and reputed company value 9. May assist with periodic audits of study files 10. May assist with file verification of regulatory documents 11. May assist with compilation and reporting of quality-reputed company metrics to management 12. 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. At least three years’ experience supporting clinical trials or IRB activities. Will consider other industry or reputed company experience. 2. Working knowledge of and the ability to interpret reputed company IRB-reputed company regulations 3. Previous experience in quality review of regulatory documents 4. BA/BS degree preferred KNOWLEDGE, SKILLS AND ABILITIES: 1. Excellent organizational and oral/written communication skills including good grammatical and proofreading skills 2. Detail oriented; ability to reputed company accurate quality review 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 COMPETENCY: To reputed company the job successfully, an individual should demonstrate the following competencies: Analytical – Synthesizes reputed company or diverse information; uses intuition and experience to compliment data 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 Language Ability – Possesses the ability to read, analyze, and interpret general business documents, SOPs, regulatory documents, technical procedures, and IRB-reputed company regulations; writes business correspondence independently; speaks effectively and presents information and reputed company reputed company; responds concisely and reputed company to questions from clients and team members. Organization – Prioritizes and plans work activities and uses time reputed company