Study Start Up Specialist
Study Start-Up Specialist
Location: San Mateo, CA (Hybrid - 3 days onsite)
Type: Full-Time, Permanent
Compensation: 75,000 - 90,000 annually + bonus + benefits
Are you passionate about clinical research and want to play a key role in bringing innovative therapies to patients?
We are partnered with a sponsor that is seeking a Study Start-Up Specialist to join our dynamic team and support the initiation of clinical trials across North America.
Responsibilities:
- Identify and evaluate potential research sites through feasibility assessments.
- Engage with site staff to foster collaboration and ensure readiness for study initiation.
- Organize and support contract negotiations.
- Prepare and submit regulatory documents to IRBs and other authorities.
- Conduct Site Initiation Visits (SIVs) and train site staff on protocols and procedures.
- Coordinate study supplies and ensure timely delivery.
- Track and report progress to ensure timely start-up of studies.
- Communicate effectively with internal teams, vendors, and research sites.
- Assist with audits, process improvements, and other clinical operations tasks.
Qualifications:
- Bachelor's degree in Biological Sciences, Nursing, Pharmacy, or related field.
- Minimum 1 year of experience as a Clinical Research Assistant or similar role.
- Working knowledge of ICH GCP guidelines.
- Strong organizational and communication skills.
- Ability to manage multiple priorities and work in a fast-paced environment.
Travel: 20 - 30% travel
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