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Position Summary:
- Experienced professional in regulatory and site start-up activities.
- Responsibilities include clinical trial submission, Informed Consent Form review, and Essential Document collection.
- May act as Subject Matter Expert and contribute to development of country-specific tools.
Essential Functions:
- Preparation of Clinical Trial Application Forms and submission dossier.
- Interaction with CA/EC for study purposes and handling responses.
- Partner with the assigned site CRA to ensure alignment in communication.
Qualifications:
- Bachelor’s degree in life sciences or Registered Nurse (RN).
- 1 year or more as a Regulatory or SU specialist in a CRO or pharmaceutical/ biotech industry.
- Strong communication and organizational skills are essential.
Precision Medicine Group
Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.