CRA/ Senior CRA Job at EPM Scientific, San Francisco County, CA

TjI4N2JUekd0NlR6eG0rTW9nUUpQaEI3M2c9PQ==
  • EPM Scientific
  • San Francisco County, CA

Job Description

Clinical Research Associate/ Senior Clinical Research Associate

San Francisco Bay Area

Salary: $90,000-$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 remote with plans to transition to hybrid with a 2-3 day in office requirement, and their entire US team is located in the SF Bay Area.

The 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:

  • Graduate qualifications in Biological Sciences, Nursing, Pharmacy or related discipline
  • At least 2 years proven experience as a CRA
  • Working knowledge of ICH GCP guidelines
  • Proven experience in managing clinical trials/project

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 Clinical Trial Specialist role, then please don't wait to apply.

Job Tags

Full time,

Similar Jobs

Get It - Executive

Chief Financial Officer (CFO) / Chief Operating Officer (COO) Job at Get It - Executive

 ...for an exceptional professional to take on the dual role of Chief Financial Officer and Chief Operating Officer. In this social justice-driven environment...  ...degree. Previous experience as a corporate controller or CFO. Familiarity with the legal industry. We offer a... 

Onward Search

Freelance Digital Art Director [78350] Job at Onward Search

Onward Search is a specialized staffing and talent solutions company that helps professionals find top jobs with the nations leading brands. We are seeking a Digital Art Director for a 6 month contract with a prestigious media and publishing company based in NYC. ...

Grace Management Group

Technical Perfumer Job at Grace Management Group

 ...Experience Level: 2-5 years of experience in technical perfumery. Bachelors Degree in Chemical Engineering, Chemistry, Biology, Cosmetic Science, Fragrance Technology or related field. We offer a competitive salary and benefits package along with a solid culture... 

Rinker Design Associates, LLC

Transportation Engineer Job at Rinker Design Associates, LLC

 ..., LLC (RDA) is seeking a skilled and motivated Transportation Engineer with 3+ years of experience to join our dynamic team in Manassas...  ...infrastructure, including roads, highways, bridges, and traffic management systems. Collaborate with multidisciplinary teams... 

Datavant

Health Information Specialist II (2045) Job at Datavant

 ...the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading...  ...: This role will be performed - Remote - WFH+ Processing medical records along with by taking calls from patients, insurance companies...