Clinical Research Regulatory Specialist I (Hybrid)
About The Position
This role requires a strong understanding of scientific concepts related to clinical trial design and analysis, including drug, device, and biological development and regulation. The specialist will ensure participant care, human subject protection, and safety in clinical research studies. Key responsibilities include study management, GCP compliance, adverse event reporting, and handling of investigational products. The position also involves facilitating communication between the site, sponsor, CRO, and regulators, emphasizing teamwork and leadership in clinical research.
Requirements
- Bachelor's Degree and some related experience
- Associate's Degree with 4 years of clinical and/or research experience
- Ability to prioritize the work of multiple projects.
- Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively.
- Write and edit technical documents.
- Ability to understand and communicate regulatory requirements to others.
- Medical terminology.
- Excellent verbal, written, interpersonal skills.
Responsibilities
- Ensures care of the participants, aspects of human subject protections and safety in the conduct of a clinical research study.
- Encompasses study management and GCP compliance; safety management (adverse event reporting) and handling of investigational product.
- Facilitates all elements of communication within the site and between the site and sponsor, CRO and regulators; understands teamwork skills critical to responsible conduct of clinical research.
- Embraces the principles and practice of leadership and professionalism in clinical research.
- Performs other duties as assigned.
- Complies with all policies and standards.
- Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
