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

eThzbnRoTEwzM0ZXNU1MRXdzS0dDbE92Q1E9PQ==
  • 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

Bullpen

Asset Manager Job at Bullpen

 ...Asset Manager (Austin, TX In Office) A well-capitalized real estate investment firm is hiring an Asset Manager to join its growing team in Austin. This is a high-impact role with direct ownership over a diverse portfolio of value-add commercial assets. The firm... 

Stevens Engineers & Constructors

Junior Construction Estimator Job at Stevens Engineers & Constructors

Stevens Engineers & Constructors has an excellent opportunity for an entry level and highly motivated Junior Estimator to join our Cleveland Operations Team, based out of our Middleburg Hts., Ohio office. This individual will be responsible for assisting the Cleveland...

DCI Donor Services

Surgical Technician/First Assistant Job at DCI Donor Services

 ...fairness, belonging, and forward thinking. Key responsibilities this position will perform include: ~ Coordinates and assists in the surgical recovery, preservation, and packaging of organs and specimens in conjunction with transplant surgeons and/or organ... 

HireGenics

Patient Trainer/Medical Device Education- PR/RN ***MUST reside within 25 miles of hiring location Job at HireGenics

 ...Job description This is not a traditional RN role. This role is focused on training...  ...hour travel back, 30 minutes administrative time Assignments fluctuate- no guaranteed set...  ...reputable medical device company is hiring part-time Patient Trainers throughout the USA.... 

Ultimate Staffing

Front Desk Receptionist Job at Ultimate Staffing

 ...other office tasks Qualifications: Previous experience in office administration or other related fields A Bachelor's degree highly preferred. The successful candidate must also be a team player with a positive attitude and effective communication skills....