Clinical Research Assoc (S)
Coordinates study activities for multiple site clinical trials, assists the Manager in training of federal regulations, policies, and industry practices related to sponsored studies, and involved in qualifying community based physicians as Principle Investigators (PI’s) and physicians’ offices as investigational sites for the conduct of clinical research.
Under general direction and with latitude for independent judgment:
Conducts investigator and site qualification visits of selected community-based physicians.
Coordinates study activities for multiple site clinical trials. Develops recruitment strategies, information and database systems, and study tracking (timeline) systems. Plans, develops and implements study design, budgets, protocols, and consents for multiple site clinical trials across various therapeutic areas. Develops, reviews and approves case report format and study-specific procedures manuals.
Serves as liaison between PI’s, pharmaceutical companies, study sites, and sponsoring and government agencies.
Ensures compliance with applicable regulatory requirements and IRB standards. Ensures integrity of all study data collected. Ensures protocol activities are administered consistently across study sites.
Trains Clinical Research Coordinators and other staff on activities associated with conducting studies according to protocols and in compliance with Good Clinical Practices (GCP’s), including training on policies and practices utilized by industry sponsors in meeting the regulatory requirements for conducting clinical research.
Keeps up-to-date with current federal regulations (i.e., FDA) for conducting clinical studies according to GCP’s. Keeps current with industry standards and therapeutic areas relevant to sponsored studies.
Bachelor’s degree and 3-5 years of experience in clinical research coordination; or an equivalent combination of education and experience. Certified Clinical Research Associate with nursing degree preferred. Experience as a pharmaceutical Clinical Research Associate preferred. Knowledge of software preferred.
NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.
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How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range: $ 58,800 - $ 82,300 Annually
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
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