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24 days old

Clinical Trial Assistant - San Diego, CA

Kelly Services
San Diego, CA 92108
**Clinical Trial Assistant - San Diego, CA**



**SUMMARY OF POSITION:**




+ Assist in all clinical team activities for start-up, oversight, and study closure to include coordinating the preparation and assembly of clinical trial supplies and materials for distribution to clinical sites with minimal/moderate supervision.

+ Maintain related tracking information of all clinical materials, shipments, and inventory.

+ Assist the Data Management team in tracking and management of Case Report Forms CRFs and Laboratory Submission Forms LSFs.

+ Assist in maintaining files and tracking of all written and electronic documentation for all study records and site interactions in the Trial Master File TMF .

+ Communicate with sites regarding query resolution to ensure compliance with specified protocols and accuracy of submitted data.

+ Participate in data entry, data auditing, clinical site queries and overall clinical data flow from multiple clinical sites in a timely and professional manner.

+ Coordinate in-house specimen procurement studies.

+ Willingness and ability to learn, understand and apply regulatory guidelines and Good Clinical Practices GCP s applicable to IVD and Medical Devices for conducting clinical field trials, CLIA Waiver and 510 k submission studies.

+ Be familiar with GCP, FDA regulations and relevant Standard Operating Procedures for clinical research.

+ Develop skill and knowledge with regulatory procedures and become familiar with product development procedures.

+ Interact with study coordinators and in-house study participants.



**ESSENTIAL FUNCTIONS:**




+ Assist with data entry as necessary, and audit field clinical trial data for inclusion in regulatory submissions.

+ Help implement and maintain clinical trial tracking databases for each clinical study.

+ Responsible for maintaining Trial Master Files for all clinical studies.

+ Works closely with the clinical team to provide clinical support.

+ May assist in the conduct of readability studies to validate ease-of-use of test materials and reliability of draft procedures.

+ Assemble and ship IUO kits and supplies for clinical studies.

+ May help clinical team identify clinical trial sites.

+ Assists in the preparation for initiation of clinical studies and monitors and tracks the progress of those studies via in-house oversight.

+ Supports obtaining IRB study approvals through direct communication with clinical sites enabling acquisition of required regulatory submission documents.

+ Recruit subjects for in-house specimen acquisition and maintains necessary supplies for specimen acquisition in support of development needs.



**INTERACTIONS:**




+ Works as a part of the clinical team, providing assistance to aid in the execution of clinical plans for clinical field studies, to include specimen procurement studies and in-house user studies.

+ Interacts via telephone and written communications with physicians, nurses, physician assistants and study site personnel at clinical trial sites.

+ Assist with in-house specimen procurement with minimal supervision.

+ Interacts with clinical team and regulatory staff to help implement, oversee and closeout clinical studies.

+ Assists with in-house monitoring and auditing of clinical data during clinical field investigations in order to achieve 100 accuracy of clinical database.

+ Works with Clinical team to assist in shipping and oversight of material supplies of clinical and beta-site field trials.



**WORK ENVIRONMENT:** Lab and office environment.



**EDUCATION, SKILLS EXPERIENCE** :




+ BS/BA in any biological science or Medical Technologist degree or equivalent combination education and/or work experience

+ 1-2 years progressive clinical research experience.

+ Previous research or scientific technical experience in the IVD, medical device or bio/pharma industry preferred.

+ Prior experience or certification in clinical trial design, Clinical Research Coordinator i.e. CCRC , and/or data management experience highly desirable



**For immediate consideration apply today!**



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




**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: 2020-09-02 Expires: 2020-10-03

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Clinical Trial Assistant - San Diego, CA

Kelly Services
San Diego, CA 92108

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