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Study Start Up Specialist - San Francisco California
Company: EPM Scientific - Phaidon International
Location: San Francisco, California
Posted On: 02/07/2025
Salary: $85-95KCompany Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Study Start Up Specialist for a hybrid role in San Francisco (Palo Alto). Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior during a year of record layoffs). Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 6 indications in Phases II and III, and are building out their clinical team to support a large Ph. III study.***** Candidate must be based in SF Bay Area to be considered.*****The Study Start Up Specialist will be responsible for: - Conducting site start-up activities and timely initiation of sites for clinical trials (1-2x per quarter)
- Feasibility assessments/visit evaluations for clinical and post-authorization studies, as required
- Supporting site management activities: investigating, following up on, and escalating site issues as needed.
- Assisting with pharmacovigilance, safety reporting management, and investigations of quality complaints.
- In-house/on-site document quality management (including, but not limited to, trial master file and investigator site file).An ideal candidate for this role MUST have---
- Graduate qualifications in Biological Sciences, Nursing, Pharmacy, or related discipline
- At least 1 year of experience as a Clinical Research Assistant or higher
- Working knowledge of ICH GCP guidelines
- Proven experience in supporting clinical trials/projectsBenefits:
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