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

Date Posted: 11/27/2021

Job Snapshot

Job Description

Clinical Research Associate II - Clinical Affairs

Summary:

The position will coordinate clinical trial process for new diagnostic products.  The process includes writing the clinical trial protocols, establishing the capabilities required for the clinical trial sites to complete the protocols, identifying sites having the proper clinical trial capabilities and managing the clinical trial sites for compliance.  Training of clinical trial sites and internal departments is required.  Coordinating the logistics of sample and data transfer will be performed.  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 the new product.  The clinical trial sites are global, therefore periodic field travel is expected.  Must have a broad understanding of clinical research, to include a working knowledge of US CFR, 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.

•       Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the  employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems.  Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.

•        Perform other duties as assigned.

Supervisory Responsibilities:

CRA I personnel and Contract Research Organization (CRO) personnel on an ‘as needed’ basis.

Education/Experience:

Requires at least a B.S. degree in Biology, Microbiology and a minimum of 5 years experience in the field of IVD or more years experience in laboratory medicine or medical technology.  The Clinical Research Associate II (CRAII) should be knowledgeable of and technically competent with all of Quest Diagnostics’ products in development and slated for clinical trials.  The CRA should have training and experience in laboratory platforms similar to those that will be used in future clinical trials.  The CRA 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.

Language Skills:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to effectively present information and respond to questions from groups of managers, clients, customers, etc.

Mathematical Skills:

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:

Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

 

Certificates, Licenses, Registrations:

CCRA (Certified Clinical Research Associate) certification preferred

 

Physical Demands:

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel.  The employee frequently is required to sit.  The employee is occasionally required to stand, walk, reach with hands and arms, and talk or hear.  The employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust Quest.

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.