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

KellyMitchell Group

Systems Administrator Job at KellyMitchell Group

 ...Job Summary: Our client is seeking a Systems Administrator to join their team! This position is located in San Francisco, California and Seattle, Washington. Duties: Participate in technology evaluations and related projects Provide data-driven recommendations... 

Tedor Pharma Services

Office Assistant - Quickbooks knowledge required Job at Tedor Pharma Services

 ...Reconcile the CIP account by project and work with the appropriate parties to determine...  ...~ Competencies ~ Ethical Conduct ~ Time Management ~ Organizational Skills ~ Financial...  ...HOURS OF WORK This is a full-time or part-time on site position. Full time requiring... 

Kromer Investments, Inc.

Brand Ambassador Job at Kromer Investments, Inc.

 ...a growing company seeking a dynamic individual to build, manage, and represent our brand from the ground up. This hybrid role combines the creativity and presence of a Brand Ambassador with the strategic oversight of a Marketing Director. The ideal candidate will shape... 

The H&K Group

Certified Payroll Compliance Specialist Job at The H&K Group

H&K Group, Inc. is searching for a Certified Payroll Compliance Specialist . Based in Skippack, PA, this role is responsible for the weekly processing and documentation of payroll prevailing wage reports. The ideal candidate is comfortable with and able to maintain...

Tax and Business Services of Oakland

Tax Preparer Job at Tax and Business Services of Oakland

 ...Tax and Business Services of Oakland is a locally trusted provider of professional tax preparation, planning, and small business consulting services. We pride ourselves on personalized...  ...closely with team members to support seasonal workload and deadlines...