Sr. Clinical Research Associate Job at GQR, Alameda, CA

SWE4dlc5d1hKbjZxRUFhQXNDR2l6TVFT
  • GQR
  • Alameda, 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

Versace

Keyholder Job at Versace

 ...Maintain client relationships through after sales service: not limited to but to include thank you notes, follow up phone calls, follow through of product repair or maintenance Support the team in generating new client relationships while maintaining those that are... 

The Planet Group

Web Programmer Job at The Planet Group

 ...The Planet Group is seeking a Web Programmer to join one of our well-known global pharmaceutical...  ...designs and functional requirements. Develop animations, navigation, other interactive...  ...and JQuery. ~ Experience with front end development of HTML-based projects such as... 

Meridia Recruitment Solutions, a KBRS Company

Building Envelope Group Leader Job at Meridia Recruitment Solutions, a KBRS Company

Building Envelope Group Leader Location: Charleston, SC or Savannah, GA Company: National Industry Leader in Building Sciences Employment Type: Full-Time About Us We are partnered with a nationally recognized leader in building envelope consulting, ...

UST

SAP Consultant Job at UST

 ...We are looking for a high-energy, SAP WM/PP Consultant. The candidate should ideally have some experience with life sciences or regulated manufacturing/pharma. If you are an experienced SAP Warehouse Management / Production Planning Consultant with excellent communication... 

Michelli Weighing & Measurement

Metrologist Job at Michelli Weighing & Measurement

 ...technicians. Accept overtime work, as necessary. Carry a cell phone when on-duty or on-call. Willing to assist other co-workers...  ...plus Low-voltage electronic instrument troubleshooting and repair. Able to handle tools to perform repair activities. Able...