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19 days old

Clinical Research Associate (CRA)- San Diego, CA

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



Every day Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. We currently have an exciting opportunity for a **Clinical Research Associate** to work with an establish company in San Diego, CA.



This a long term 1 year contract positoin and candidate must be able to travel up to 50%.



**Summary:**



Working under the direction of the Trial Manager, the Clinical Research Associate, CRA, works with supervision in all operational phases of the clinical study, including site selection, IRB submission, site start up, monitoring, and close out. The CRA will review study protocols, ICFs, CRFs, monitoring plans, and other study documents. The CRA will help plan and conduct site initiation (including onsite training and setup), study source data review and verification. The CRA will also verify that onsite testing has been correctly conducted and recorded, that biological specimens have been appropriately handled, stored, labelled, and shipped, and that investigational product accountability has been properly documented.



This position requires up to approximately 50% travel. When not traveling this position assists with in-house clinical team activities, such as assembly of clinical study supplies and materials, instrument configuration, inventory, shipment and tracking of study materials, maintenance of files and records in the Trial Master File (TMF), data entry and data management activities.



The CRA must understand and apply regulatory guidelines and GCPs applicable 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.



**Additional responsibilities include:**




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

+ Ensure sites are following the clinical study protocol, GCP, and all applicable regulations

+ Conduct study site selection, qualification, training, start up, and close out

+ Support IRB submissions

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

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

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

+ Assist with data entry as necessary

+ Maintain Trial Master Files for all assigned clinical studies

+ Assemble and ship IUO kits and supplies for clinical studies

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

+ Responsible for oversight and interaction with personnel at external study sites



**Job Requirements:**




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

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

+ Must be able to travel at least 50%.

+ Strong knowledge of GCP is required.

+ Bachelors degree 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.



**APPLY TODAY! Questions? Contact Kevin at Kevin.Lau@kellyscientific.com**






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



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing 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 95 of the Fortune 100 companies, and found opportunities for more than 9,000
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.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.

Categories

Posted: 2019-08-05 Expires: 2019-09-12

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Clinical Research Associate (CRA)- San Diego, CA

Kelly Services
San Diego, CA 92108

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