Job Description

Senior Clinical Research Associate

San Francisco Bay Area

Salary: $115,000-$130,000

A global specialty biopharma company is looking for new members to join their clinical team on a full time basis as they ramp up a large global Ph. 3 study.

They currently have 8 indications across 2 programs ranging from preclinical to Ph. 3. They've also had 3 approvals in various global markets for their lead asset. This company has had year over year revenue growth for the past three years.

This role is hybrid with a 2-3 day in office requirement, and their entire US team is located in the SF Bay Area.

The Senior Clinical Research Associate will be responsible for:

• Oversee site management, including the supply of materials, payment processes, and related activities.
• Manage site setup, initiation, monitoring, close-out, and overall management of clinical and post-authorization study sites on an as-needed basis.
• Collaborate with the Clinical Project Manager or designee for site evaluation and setup related to commercial distribution, including dosing training.
• Track and report on the status of clinical trials and studies, providing regular progress updates to the team.
• Oversee data collection and pharmacovigilance/safety reporting at post-authorization study sites.
• Ensure the collection of essential documents in compliance with ICH-GCP E6 (R2) and applicable regulations.
• Prepare and submit regulatory documents to EC/IRB and other relevant bodies.
• Maintain relationships with commercial distribution sites and those involved in clinical trials.
• Participate in investigator meetings

The Clinical Research Associate should have the following qualifications:

• At least 3 years of independant monitoring experience in clincal trials
• Experience working on drug development trials
• Working knowledge of ICH GCP guidelines
• Proven experience in managing clinical trials/project
• Bachelors Degree required
  

Benefits:

• A competitive salary with benefits.
• A real hands-on opportunity to gain a high degree of commercial exposure.
• Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery

If you are interested in the Sr. CRA role, then please don't wait to apply.

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