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

tmc

Certified Occupational Therapy Assistant Job at tmc

TMC is a therapy provider that brings physical, occupational, and speech therapy services to long term care providers. We are growing and looking for a Certified Occupational Therapy Assistant to join the team. We want a COTA that believes in the benefits of occupational... 

Williamson Health

Occupational Therapist - Certified Hand Therapist - Full Time Days Job at Williamson Health

 ...an equal-opportunity employer and a drug-free workplace. POSITION SUMMARY The Occupational Therapist is responsible for organizing and conducting occupational therapy interventions in the organization to restore function and prevent disability following disease... 

LongHorn Steakhouse

Line Cook Job at LongHorn Steakhouse

 ...bold and flavorful food... and we want you to join us. Let's get Fired Up! Combining quality and bold FLAVOR starts with our Line Cooks. They bring it... every steak, every time. Get our Guests Fired Up by... Prepares high quality food items to order... 

Sanford Health

RN Clinical Research Coordinator - Diabetes Job at Sanford Health

 ...participation in educating patients, physicians, nurses and other personnel to the research process. Advanced nursing position that involves clinical patient contact, research study coordination and study data management. Must be able to organize complex components of... 

Allied Universal

Security Officer Airport Foot Patrol Job at Allied Universal

 ...contributes to a culture that positively impacts the communities and customers we serve. We offer comprehensive benefits for most full-time...  ...***Pay Rate: $21.00 / Hour****Santa Ana Area**As a Security Officer, you will serve and safeguard clients in a range of industries...