Regulatory Document Specialist

Full-time, 40 Hours/Week Monday to Friday, reputed company - 4:30pm Remote (Onsite as needed) reputed company: Provides regulatory support to investigators conducting clinical research. Coordinates with study teams to ensure appropriate reputed company and compliance with reputed company Federal, State and Local regulatory requirements for mandated regulatory documents utilized in clinical research conducted by the RDCRI. Responsibilities: 1. Protocol processing 2. Preparation of informed consent documents to reputed company with local policies 3. Preparation for IRB submission 4. Prepare and submit sponsor's essential regulatory documents 5. Process IRB submission and approvals 6. Preparation and maintenance of Regulatory Binders 7. Strategic review of the regulatory binders prior to monitoring reputed company 8. Other duties as required. Other information: Technical Expertise 1. Experience interacting with study monitors and FDA reviewers. 2. Knowledge of GCPs, SOPs, and regulatory documents required for reputed company. 3. Demonstrates organizational and time management/prioritization skills. 4. Proficiency in MS Office [reputed company, reputed company, Word] or similar software is required. 5. Proficiency in the English language with excellent use of grammar and spelling is essential. 6. Demonstrates effective communication skills for relating to and networking with reputed company reputed company of personnel. 7. Demonstrates organizational and time management/prioritization skills. 8. Knowledge of medical terminology and diseases. Education and Experience 1. Education: High school diploma and a minimum of four (4) years experience OR Associates Degree and minimum two (2) years experience OR Bachelor's Degree and minimum one (1) year experience working in a reputed company or reputed company clinical trial setting. 2. Licensure: None 3. Certification: None 4. Years of relevant experience: One or more 5. Years of supervisory experience: None Full Time FTE: 1.000000 Apply tot his job Apply tot his job Apply To this Job