Sr. Clinical Research Associate Job at GQR, San Mateo, CA

UzhkQ2hvbkxzc0h0N09LWDRrd1pvMnRTZHc9PQ==
  • GQR
  • San Mateo, 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

Michaels Fence & Supply

Residential Fence Installer Job at Michaels Fence & Supply

 ...Job Description Job Description Michaels Fence has been the industry leader since 1971, holding the standard high in this profession. We specialize in vinyl, ornamental iron, and chain link fencing. After being voted the #1 'Local Best' Fence Contractor in Sioux Falls... 

Valle Verde - a HumanGood community

Security Guard, Part Time Weekends Job at Valle Verde - a HumanGood community

 ...Under general supervision, the Security Officer promotes and maintains a safe and secure environment...  ...hr Shift Differential for working on the night shift Education High School Diploma...  ...Experience/Training Prior security guard experience preferred. Certificates,... 

Montefiore Health System

APPLICATION ANALYST EPIC CLINDOC Job at Montefiore Health System

 ...operations teams. Montefiore is actively investing in its technology teams as a system-level priority, and we are seeking an Application Analyst to join our Epic team.Montefiore requires employees to reside in NY, NJ, CT, or PA and to be immunized, including for COVID.... 

Tomra

CDL A Driver Job at Tomra

Company Description TOMRA, an international recycling company, is looking for a CDL-A Route Driver in Syracuse, NY. PAY: $27/hr Job Description Prepares, receives and provides appropriate documentation for the delivery or pick up of goods to ensure timely service... 

H & R Roofing of South Dakota Inc.

Roofers Job at H & R Roofing of South Dakota Inc.

Job Description Locally owned and operated commerial / industrial roofing company now hiring construction workers for projects in the Sioux Falls SD area. H & R Roofing has been providing quality roofing services since 1971. H & R Roofing is an equal opportunity employer...