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Kelly Services Clinical Research Assistant in Cleveland, Ohio

Clinical Research

Kelly Science & Clinical is working with a Cleveland based hospital to identifying candidates for a Clinical Research Assistant position supporting a local hospital

Day Shift position- hybrid work schedule 1/2 home & 1/2 time in the office

Location- Cleveland Ohio

Position Summary/Essential Duties:

  1. Coordination and facilitation of the daily operations including the development and implementation of new projects (study development, grant/technical writing) and implementing current and new studies (data collection of patient data from those sites, ensuring that each participating site follows policies and procedures as outlines in the Standard Operating Procedures Manuals).

  2. Oversight of program and office coordinators for study and regulatory operations in protocols including startup, maintenance and closeout for multiple multi-center, international clinical research studies, protocol compliance, regulatory documentation, quality control, data monitoring and reporting, Institutional Review Board (IRB) submissions, human subject protection, coordination of invoicing with administration and supervision of coordinator activities.

  3. Devise and implement new study-specific protocols and techniques which include required study procedures (site manuals, study parameters, grader manuals and certification, programming documentation, external compliance vendor validation, QA implementation, etc.).

  4. Data analysis for federal and corporate clinical research studies as related to natural history, surgical, pharmacologic and device intervention, safety and efficacy studies.

  5. Meet biweekly with external compliance vendor to audit study-specific procedures for evaluation of quality control related to each specific study and its parameters in order to evaluate the adequacy of study grading, to monitor inter- and intra-observer reliability and data drift over the life of the study.

  6. Implement study procedures and tracking mechanisms to ensure studies are all on track in relation to start up, site certification, grading, and data transfer. Communicate with pharmaceutical companies / study Sponsors, reading center staff (20 employees) and clinical sites, ensuring clear, smooth processes for correspondence and issue resolution.

  7. Supervise training, including orientation for new students, task- and SOP-related training, and regular staff meetings.

Education/Expertise: Postsecondary degree required (Associates/Bachelors) and 3 years of clinical research experience. In lieu of degree requirements must have 7 or more years of clinical research experience.

SoCRA Certified Clinical Research Professional required within 6 months of hire.

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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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)