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23 days old

Sr. Clinical Research Associate

Kelly Services
Elk Grove Village, IL 60007
Kelly Science & Clinical has an excellent opportunity for a Sr. CRA located near Elk Grove Village, IL


**POSITION SUMMARY:**


The Sr. Clinical Research Associate will be responsible for the execution of IVD clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various stages or phases in the life cycle of the product including alpha (early stage feasibility), beta and most importantly the clinical studies that validate the product.


**ESSENTIAL JOB RESPONSIBILITIES:**


+ Perform internal performance testing such as proficiency and system testing

+ Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products

+ Identify potential investigators, prepare site budgets and contract agreements

+ Collect, review and process regulatory documents and correspondence from participating trial sites

+ Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as required.

+ Develop and implement study specific tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution

+ Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits

+ Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem

+ Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance

+ Ensure that studies adhere to FDA regulations, Good Clinical Practices, and IVD directives


**MINIMUM REQUIREMENTS:**


**Education and Experience:**


+ Bachelor's degree in a scientific discipline Required (Chemistry, Biochemistry, Biology, or Microbiology)

+ Minimum of 3-4 years of strong Monitoring experience


+ Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment

+ Excellent communication and team skills

+ Effective interpersonal skills

+ Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.

+ Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.

+ Knowledge of GCP & ICH guidelines and FDA regulations


Other:


+ Currently 100% remote based. Must be able to travel up to 30% when restrictions lifted

+ Long term contract with potential for Temp-Hire


\#ACRP


**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: 2021-05-21 Expires: 2021-07-05

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Sr. Clinical Research Associate

Kelly Services
Elk Grove Village, IL 60007

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