The Regulatory Clinical Research Coordinator is a health professional possessing analytical and communication skills, knowledge of FDA/GCP/NIH guidelines, knowledge of IRB policies and procedures, knowledge of data management activities and a willingness to cooperate as a team member. The Regulatory Clinical Research Coordinator performs duties related to the support and regulatory coordination of clinical studies. Occasional travel and overtime may be required.REQUIRED
- Knowledge of clinical research trials regulations (e.g., Food and Drug Administration [FDA] and Office for Human Research Protections [OHRP]) is essential.
- Knowledge of IRB policies and procedures.
- Analytical skills to evaluate information, practices and procedures, formulate logical and objective conclusions and make recommendations for effective solutions.
- Experience with Microsoft Word, Excel, Adobe Acrobat; experience with electronic databases and websites for submission and retrieval of documents
- Tracking and recordkeeping experience or skills.
- Organizational skills and attention to detail in maintaining large volumes of records, setting priorities, following through on assigned tasks and adhering to deadlines in a timely manner.
- Writing skills to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms.
- Knowledge and understanding of oncology and disease processes as applied to clinical research.
- Experience working individually and as a team member in a diverse workforce.
- Skills to analyze and interpret federal, local, and institutional regulatory changes and decide how they will impact internal processes.
- THIS POSITION MAY BE SUBJECT TO A CRIMINAL BACKGROUND INVESTIGATION, DRUG SCREEN, LIVE SCAN FINGERPRINTING, MEDICAL EVALUATION CLEARANCE, AND FUNCTIONAL CAPACITY ASSESSMENT