Clinical Research Regulatory Coordinator - Location: Los Angeles, CA
- Type: Contract
- Job #84367
APR Consulting, Inc. has been engaged to identify a Clinical Research Regulatory Coordinator Location: Los Angeles, CA 90025 Position: Clinical Research Regulatory Coordinator Pay Rate: $45.26/hr Duration: 13 weeks Expected Shift: 40 hrs/week 8am to 5pm 100% Onsite Required: * Bachelor's Degree * 3 years of relevant clinic research experience * Regulatory Experience - Ability to strictly adhere to regulatory requirements and ethical guidelines * Experience with EDC systems (Medidata, VeevaVault, MedRio) Preferred: * Experience with Oncology/Chemo * CCRP strongly preferred Primary Duties and Responsibilities • Submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices. • Completes forms and generates reports from multiple data sources to comply with the assigned protocols for the study and/or clinical trial. • Maintains research files and may audit documentation pertaining to regulatory requirements for clinical trials. • Responds to generally broad data requests and questions. • Monitors the status of assigned regulatory submissions and amendments from end-to-end. • Partners with research staff and investigators to ensure that all regulatory documents for the assigned research studies are up to date. • Represents the unit in cross-functional meetings and provides updates on the status of assigned regulatory submissions. • Supports the unit in internal and external auditing of regulatory documents. • Identifies quality and performance improvement opportunities to support efficient workflows. • Maintains strict patient confidentiality according to HIPAA regulations and follows guidance according to applicable law, research practices using Good Clinical Practice (GCP) guidelines. Our client is the one of the largest Healthcare Staffing Provider in the United States, to be assigned at one of their affiliated hospitals/healthcare facilities. This particular client is requiring that all new hires show proof of vaccination. However, accommodations may be made for those with disabilities or religious reasons who cannot obtain a vaccine. Since 1980 APR Consulting, Inc. has provided professional recruiting and contingent workforce solutions to a diverse mix of clients, industries, and skill sets nationwide. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Don't miss out on this amazing opportunity! If you feel your experience is a match for this position please apply today and join our team. We look forward to working with you!