Kelly Science & Clinical has an excellent opportunity for a Sr. CRA located near Elk Grove Village, IL
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
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
Currently 100% remote based. Must be able to travel up to 30% when restrictions lifted
Long term contract with potential for Temp-Hire
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