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1+ months

Clinical Trial Assistant

Kelly Services
Jacksonville, FL 32232
Kelly Science & Clinical is currently seeking a **Clinical Study Assistant** for a long-term engagement with one of our Global Medical Device clients in Jacksonville FL.


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**SUMMARY**


This position supports clinical studies from study start-up through close-out. The Clinical Study Assistant is responsible for supporting Clinical Operation Managers (COM) and Clinical Research Associates (CRA), to ensure clinical study documentation (trial master file) is complete, accurate and on file according to standard operating procedure, as well as assist with clinical trial progress tracking and reporting as required.


The CSA position will adhere to safety and environmental policies and procedures and support department objectives.


**ESSENTIAL FUNCTIONS**


+ Enter and maintain required documentation in study specific databases related to purchases, contracts, health care compliance, study document management, and other areas as required

+ Responsible for the set-up of the Trial Master File, investigator study file binders and regulatory document collection

+ Review protocols and study documents to ensure consistency and accuracy

+ Coordinate and plan investigator meetings, site training, and other company functions

+ File and review all appropriate test article accountability reconciliation form from study sites

+ Other duties as assigned


**RESPONSIBILITIES**


+ The expectation is that this position can independently handle collecting legal documents and contracts through the appropriate channels to be approved and payments initiated. Invoices must be collected, quality checked, and reconciled against milestones stated in the applicable contracts per Sarbanes Oxley.

+ Using the appropriate system applications, this position is accountable for the following activities:

+ Obtain CR (Protocol) number

+ Create Trial Master File

+ Generate site regulatory binders

+ Perform debarment checks

+ Review, track, scan and upload regulatory documents to eTMF, and file in TMF

+ Schedule and set up Site Initiation Training meetings

+ Work with on-site printing vendor as required to generate study documents (e.g., ICFs, assents, questionnaires, instructions)

+ Request and submit Research Agreements for approval

+ Field all study-related questions and document in communication file in TMF

+ Regular TMF review

+ Schedule meetings, generate and publish meeting minutes

+ Keep calendar

+ Create transaction records in and upload documents to the appropriate systems

+ Format and finalize draft protocols to Regulatory and SOP standards

+ Initiate document review, approval and finalizing processes

+ Track, reconcile, and report budget and payments

+ Supplier set up and database maintenance


**QUALIFICATIONS**


+ Bachelors degree or higher from an accredited institution and 1-2 years Clinical Trial Coordinator I, or 3+ years' related clinical experience.

+ Strong organizational skills

+ Computer skills required:

+ Microsoft Office products Word, Excel, PowerPoint, Project, and SharePoint

+ Ability to work with minimal supervision in a Team environment

+ The ability to understand written work instructions and follow the requirements

+ Highly developed communication skills to include all levels of an organization

+ 1 years leadership experience preferred

+ Knowledge of FDA guidelines, regulations and/or Good Clinical Practice a strong plus


Location: Jacksonville, FL 32256


Send your resume: erlin.golubski@kellyservices.com


**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: 2022-02-25 Expires: 2022-05-30

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Clinical Trial Assistant

Kelly Services
Jacksonville, FL 32232

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