Job Details

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. This role requires the candidate to work onsite, please only apply if you are local or willing to relocate.

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.