Clinical Research Associate II in San Juan Capistrano, CA at Quest Diagnostics

Date Posted: 12/27/2021

Job Snapshot

Job Description

Clinical Research Associate II – IVD

Summary:

The position will coordinate clinical trial process for new IVD assays for diagnostic products.  The incumbent in this role will prepare analytical clinical trial protocols for 510k, IRB, DE NOVO, PMA or related in partnership with various pharma. partners. The post-clinical trial activities of this position include coordinating cross-functional teams to launch a new product or device, ensure publications and white papers are available, and assist in the pre-market positioning of clinical and analytical post-clinical data.  The CRA II will support in-house (single site investigations) monitoring activities. (Periodic field travel is expected.)  The incumbent in this role must possess broad understanding of clinical research and trial monitoring activities, to include a working knowledge of US CFR Part 812 & 50, ICH, EU, Canadian and GCP Guidelines.

Responsibilities:

•         In collaboration with other Quest staff, identify potential external sites for the evaluation of new Quest IVDs and performance of clinical trials.

•         Perform detailed investigations, including site visits, to evaluate the technical capability of potential external collaborators.

•         Participate in the identification of collaborators that can provide critical clinical specimens for R&D feasibility and verification studies and for manufacturing validation studies.

•         Participate in the development of clinical trial protocols, which will include evaluation of the individual site’s technical and logistical capabilities to perform the protocols.

•         Responsible for IRB submissions, annual reports and maintenance of related documentation and Trial Master Files.

•         Coordinate the clinical specimen acquisition process.

•         Coordinate any training required at external collaboration sites, including conducting on-site training.

•         Monitor the performance of clinical trial sites by reviewing procedures, personnel and data generated at the sites including period visits to clinical trial sites.

•         Serve as the coordinator of cross-functional departments and teams such as R&D, manufacturing, Regulatory Affairs, Operations to bring products through the regulatory process and launched to the market.

•         Oversee and work closely with the clinical trial sites to ensure clinical trial data is published in peer-reviewed journals or other appropriate platforms. Key is to ensure accuracy of results while meeting timelines.

•         Research technical questions through review of periodicals, interaction with in-house personnel, the Internet, and any other resource.

•        Perform other duties as assigned.

Education/Experience:

B.S. degree required, concentrations in Biology, Microbiology or related preferred.

Minimum of 5 years experience in the field of Clinical trial monitoring, coupled with experience in medical device, IVD, laboratory medicine or medical technology. 

The Clinical Research Associate II (CRAII) should become knowledgeable of and technically competent with all of Quest Diagnostics’ products in development and slated for clinical trials. 

The CRA II should have training and experience in laboratory platforms similar to those that will be used in future clinical trials, and should also have experience and be competent in interacting and communicating with external collaborators and clients.  

The position requires the maintenance of documentation to meet specific quality standards.  The applicant should have excellent communication, project management, time management, and people skills and be proficient in MS Office applications.

 

Certificates, Licenses, Registrations:

CCRA (Certified Clinical Research Associate) certification preferred.

 

Work Environment:

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals.  The noise level in the work environment is usually moderate.