Study Start Up Specialist

Company: EPM Scientific - Phaidon International
Location: San Francisco
Posted on: October 10, 2024

Job Description:

Salary: $80-90KCompany 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:
    • Competitive salary with benefits
    • High degree of commercial exposure early in your career
    • Being a part of team whose work directly aims to improve the quality of people's lives
    • Great work-life balanceIf you are interested in this Study Start Up Specialist role, don't hesitate to reach out!
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Keywords: EPM Scientific - Phaidon International, Santa Cruz , Study Start Up Specialist, Other , San Francisco, California