Clinical Research Coordinator 2

About The Unit:

Unit Job Summary: Under the general direction of Anil Lal, Executive Administrator, the individual will manage all aspect of conducting clinical trials from startup to closeout for multiple concurrent moderately complex clinical trials that may include national level, multi-institutional pharmaceutical trials and multi-centered cooperative group and intergroup studies. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence. Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events. Responsible for the oversight/monitoring of all clinical trial expenses; reviews the protocol plan to differentiate standard of care versus research to ensure that clinical care expenses, personnel effort, site initiation costs, IRB fees, pharmacy costs, equipment, and supplies are tracked and captured as direct costs to the clinical trial. Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, noting severity and causality and attribution of the adverse events; reports findings to PI, sponsor and IRB under general direction of department, clinical research manager and/or the Office Clinical Research. Organizes and actively participates in site visits from sponsors and other relevant study meetings. Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.

Unit Education: Bachelor's degree required.

Unit Experience: Minimum of 2 years of clinical research experience or relevant experience required. Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials) required.

Unit Job Function Competencies: Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines required. Demonstrated ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others required. Ability to communicate with tact and diplomacy required. Strong organizational skills required. Strong communication skills (verbal and written) required. Ability to handle sensitive matters with tact and discretion required. Excellent interpersonal skills required. Strong data management skills and attention to detail required. Ability to participate in protocol review and clinical trials evaluations required. Knowledge of medical terminology / environment required. Ability to handle competing demands with diplomacy and enthusiasm required. Excellent time management and ability to prioritize work assignments required. Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat required. Familiarity with Good Clinical Practices (GCP) required. Ability to read and understand clinical trials protocols required. Understanding of the IRB submission and review process and when and how to apply for IRB review required. Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation required. Ability to absorb large amounts of information quickly required. Adaptability to changing working situations and work assignments required.

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