CRA/ Senior CRA

EPM Scientific; California (MO); Remote; USD 90,000 - 130,000; Full time

Job summary

A global biopharma company is seeking a Clinical Research Associate to join their team, overseeing clinical trial management and ensuring compliance with regulations. The role offers a competitive salary and the opportunity to work with a talented team in a fast-growing environment. This remote position has plans to transition to a hybrid model.

Benefits

Competitive salary with benefits

Hands-on opportunity with commercial exposure

Qualifications

• At least 2 years proven experience as a CRA.
• Working knowledge of ICH GCP guidelines.
• Proven experience in managing clinical trials/project.

Responsibilities

• Oversee site management, including the supply of materials and payment processes.
• Manage site setup, initiation, monitoring, and close-out of clinical trials.
• Ensure the collection of essential documents in compliance with ICH-GCP E6.

Skills

Clinical Trial Management

Data Collection

Pharmacovigilance

Site Management

Education

Graduate qualifications in Biological Sciences, Nursing, Pharmacy or related discipline

Job description

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This range is provided by EPM Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$90,000.00/yr - $130,000.00/yr

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Recruitment Consultant at EPM Scientific

Clinical Research Associate/ Senior Clinical Research Associate

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
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  Pharmaceutical Manufacturing

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