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26 days old

Clinical Trial Assistant

Kelly Services
North Wales, PA 19454
**Clinical Trial Assistant**


**Position Summary:**


This position is within the BA Logistics Data Oversight group. The Clinical Trial Assistant will:


Work with staff in Biologics Development Sciences BDS to manage the internal database for early phase clinical study specimen metadata and results obtained from the analysis of these biological specimens conducted at External Service Providers ESPs .


Set up LIMS database study templates, upload, and extract data.


**Core Responsibilities:**


+ Review sample and data flow specifications documents from internal groups and Central Laboratories.

+ Create data transfer agreements per departmental guidelines.

+ Define studies in ClinPharm LIMS for early phase clinical studies where bioanalysis will be conducted at ESPs so that biological specimens metadata can be uploaded and tracked.

+ Update the metadata based on reconciliation activities.

+ Internalize data sets into Watson LIMS as appropriate.

+ Oversee shipments from BDS to ESPs, including generation of shipping manifests and requests for shipment to the Sample Storage Center SSC .

+ Investigate missing shipments, biological specimens, and incorrect metadata as applicable.

+ Deliver bioanalytical results to Clinical Pharmacology and Pharmacometrics and Global Clinical Development Operations Integrated Data Analytics Reporting.


This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.


**Other Responsibilities (if any):**


+ Serve as database resource for BDS staff.

+ May provide additional support to the BA Logistics and Data Oversight group as needed.


**Education & Experience:**


+ Education: B.S. / B.A. in related discipline required.

+ A minimum of 2 years experience working in database systems.


**Experience/Special Skills:**


+ Previous experience with pharmaceutical industry, clinical study data management, or laboratory information database s is preferred.

+ Experience with Watson LIMS preferred.

+ Demonstrated problem solving and decision-making skills required.

+ Excellent oral and written communication skills required.

+ Ability to work in a team environment and collaborate with peers in a professional manner required.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-04-22 Expires: 2022-05-23

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Clinical Trial Assistant

Kelly Services
North Wales, PA 19454

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