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12 days old

Clinical Research Associate - San Diego, CA

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



**This is a 1 year long term temporary position with potential to hire on!**



**Summary:**



Working under minimal supervision and under the direction of the Trial Manager, the CRA takes a lead role in all operational phases of the clinical study, including site selection and contracting, IRB submission, site start up, monitoring, and close out. The CRA will facilitate the development and review of study protocols, ICFs, CRFs, monitoring plans, and other study documents. The CRA will independently plan and conduct site initiation (including onsite training and setup), study source data review and verification.


**Responsibilities:**




+ Ensure clinical study data are accurate via source verification, query initiation and resolution

+ Support IRB submissions

+ Act as a primary contact between the site and the study sponsor

+ Summarize, analyze, and prepare clinical study data, including clinical and regulatory reports

+ Ensure proper inventory, storage, shipment, and tracking of study materials

+ Ensure proper handling, storage, tracking, and shipment of clinical specimens

+ Act as a mentor and resource to junior clinical team members

+ Maintain Trial Master Files for all assigned clinical studies

+ Assemble and ship IUO kits and supplies for clinical studies

+ Understand and apply regulatory guidelines and GCPs to in vitro diagnostics (IVD) and Medical Devices for conducting clinical field trials, CLIA waiver and 510k submission studies

+ Ensure compliance U.S. QSR and ISO9000 regulations, Good Clinical Practice, FDA regulations and relevant Standard Operating Procedures for clinical research.

+ Works with the Clinical Trial Manager to represent the clinical department as a part of a multidisciplinary team, providing guidance and executing plans for clinical field-testing requirements

+ Assumes a lead role in the oversight and interaction with personnel at external study sites

+ Supports product development teams and the regulatory department on study design, protocol development and data analysis to achieve intended use claims



**Minimum Requirements:**




+ Requires a BS/BA in biology, chemistry, or related scientific or engineering field or equivalent combination education and/or work experience

+ A minimum of five (5) years direct experience in clinical study monitoring is required

+ Experience in IVD is preferred, with a proven track record of progressive clinical study responsibility

+ Detail-oriented with a high level of organizational skills; good written and verbal communication skills; excellent interpersonal skills, always maintains professionalism, with ability to resolve conflict

+ Advanced computer skills (Word, Excel, Outlook, Access) or equivalent are required

+ Experience with electronic data management systems is preferred

+ Understanding of relevant ISO Regulations and GCP is required



**QUESTIONS? Contact Kevin at kevin.lau@kellyscientific.com or 623-688-2142**




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



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-11-20 Expires: 2020-12-21

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Clinical Research Associate - San Diego, CA

Kelly Services
San Diego, CA 92108

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