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8 days old

Clinical Research Associate (CRA) - San Diego, CA

Kelly Services
San Diego, CA 92108
**Clinical Research Associate (CRA), San Diego, CA**



The Clinical Research Associate works closely with project teams to provide clinical guidance, develop clinical trial protocols and help design associated clinical forms, including CRFs, DRFS, etc. for field studies.



The position sets up, oversees and monitors all aspects of clinical trials in all diagnostic areas assigned.



**Additional responsibilities include:**




+ Sets up, oversees and monitors all aspects of clinical trials in all diagnostic areas assigned. Understands and applies regulatory guidelines and GCPs (good clinical practices) applicable to IVD (in-vitro diagnostics and medical devices) for conducting clinical field trials, CLIA waiver and 510k submission studies.

+ Performs site selection and conduct initiation visits including the training of site study personnel on study procedures and requirements. Assists in the development of site specific and overall study budgets to include contract negotiation.

+ Assists in the development and review of protocols, informed consents, and case report forms (CRFs), data report forms (DRFs) and any additional study documents necessary.

+ Retrieves and reviews required regulatory documentation and the collection and formulation of all study data.

+ Participates in analysis of data to include writing of final clinical study reports. Maintains a high level of professional expertise through familiarity with clinical literature and current regulatory requirements such as U.S. CFR, QSR and ISO 1345.

+ Travels to field sites to monitor clinical studies and acts as a liaison between study sites and team members.

+ Works closely with project teams to provide clinical guidance, develop clinical trial protocols and help design associated clinical forms, including CRFs, DRFS, etc. for field studies.

+ Summarizes, analyzes and prepares field clinical trial data for inclusion in regulatory submissions and designs and maintains clinical trial databases and clinical files.

+ Monitors and audits field clinical trial sites during clinical field investigations and specimen procurement, internal readability, and CLIA studies.

+ Procures, manages and processes clinical specimens in support of development needs and ensures proper storage and tracking of all in-house clinical specimens.

+ Supports obtaining Institutional Review Board (IRB) study approvals from clinical sites, assists in submission of institutional review board or ethics committee (EC) documents as required for clinical studies performed at company or sponsor required documents for field studies. Interacts with product development and regulatory teams on study design, protocol development, and data analysis in order to achieve intended use claims.

+ Works closely with R & D and/or marketing to develop beta-site trial protocols and manage ongoing study project needs. Acts with minimal supervision to determine methods and procedures on new assignments. Works on assignments that are moderately complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.

+ Carries out duties in compliance with established business policies.



**Job Requirements:**




+ The ideal candidate will have at least 2 years of clinical data monitoring experience, both in-house and in the field.

+ Experience at a sponsor company is preferred, but not required.

+ Must be able to travel at least 50%.

+ Strong knowledge of GCP is required.

+ Bachelors degree (BS) in a science field is preferred, but not required with sufficient experience.

+ Motivated, detail-oriented candidates with strong communication and interpersonal skills will be considered favorably.



**For immediate consideration apply today!**



**Questions? Please reach out to Dustin at dusg877@kellyservices.com**






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-01-10 Expires: 2020-02-10

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Clinical Research Associate (CRA) - San Diego, CA

Kelly Services
San Diego, CA 92108

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