Sr. Clinical Research Associate Job at GQR, Santa Rosa, CA

QzYxb0VINkhiNWdhNkw5d2tBTlovSWpYZVE9PQ==
  • GQR
  • Santa Rosa, CA

Job Description

Title: Sr. Clinical Research Associate- Contract

Location: Remote-based, local to San Francisco. or West Coast required

Duration: 6 months

Compensation: $85 to $90 depending on experience

Please note, this position requires recent (within the last 2-4 years) experience working on the sponsor side of clinical studies.

The Senior Clinical Research Associate (Sr CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study. This position works closely with a cross-functional team, vendors, sites, and CRO to ensure compliance with protocol and the overall clinical trial objectives.

Day to day duties

  • Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to SOPs, ICH/GCP, and corporate and departmental program goals.
  • Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately.
  • Participates in protocol development, tracking changes for future protocol amendments, and works with medical writing to initiate protocol amendments as needed.
  • Oversees aspects of study management and vendors (e.g. IRT, eCOA, cardiac safety, patient reimbursement vendors) to ensure high quality of data and to ensure study execution and deliverables are met with minimum supervision.
  • Overall management of selected clinical sites including acting as a point of escalation and oversight of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with clinical sites. Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.

Necessary Qualifications

  • Bachelor’s degree in a relevant scientific discipline
  • Minimum 4 years of clinical trial management experience working for a Sponsor company.
  • A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology.

Job Tags

Contract work, Local area, Remote job,

Similar Jobs

St. Joe County Public Library

Public Library Customer Service Senior Manager Job at St. Joe County Public Library

 ...St. Joe County Public Library provided pay range This range is provided by St. Joe County Public Library. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range $69,097.00/yr - $100,194.00/yr Pay... 

Bristol-Myers Squibb

Supplier Quality Manager Job at Bristol-Myers Squibb

 ...With Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production... 

Bristol Myers Squibb

Executive Director, Clinical Development Program Lead (Neuropsychiatry) Job at Bristol Myers Squibb

 ...with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production... 

MINA, PLLC

Emergency Medicine Physician Job at MINA, PLLC

 ...summary: Locum tenens Emergency Medicine Physician role at a Level 1 trauma hospital in Central New York, covering ED/ICU/clinic shifts (day, night, swing) for a long-term assignment (6+ months) at ~15 shifts/month. Facility: 197-bed hospital, 28 ED beds, high-acuity... 

The Curare Group

Reno Area Primary Care Job Offers J-1 Visa Sponsorship Job at The Curare Group

 ...outpatient only, Monday-Friday, no call no weekends Primary Care opportunity in which you will be seeing 20+ patients per day. J-1 visa sponsorship is also available. Spend your time exploring all of the outdoor amenities Lake Tahoe has to offer. Practice...