Study Start Up Specialist

Salary: $80-90K
Company 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 requiredSupporting 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 disciplineAt least 1 year of experience as a Clinical Research Assistant or higherWorking knowledge of ICH GCP guidelinesProven experience in supporting clinical trials/projectsBenefits:
Competitive salary with benefitsHigh degree of commercial exposure early in your careerBeing a part of team whose work directly aims to improve the quality of people's livesGreat work-life balanceIf you are interested in this Study Start Up Specialist role, don't hesitate to reach out!

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