Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
Provide Investigators with guidance regarding protocol requirements.
Maintain regulatory documentation.
Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.
Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
Serve as a resource person or act as a consultant within area of clinical expertise.
Act as a leader within the department/unit through improving clinical research practice and serving as a resource.
Maintain working knowledge of current protocols, and internal SOPs.
Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
Provide direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), as applicable based on investigator and departmental needs.
Attend continuing education and training opportunities relevant to job duties.
Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research.
Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.
Performs other related work as needed.
Minimum of 2-5 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials)
Experience coordinating multiple and a variety of studies (e.g., investigator initiated, industry sponsored, multi-site trials)
Research certification (e.g., SoCRA, ACRP, Graham School Clinical Trials Management & Regulatory Compliance)
Ability to train junior CRCs
Ability to participate in protocol review and clinical trials evaluations
Excellent interpersonal skills
Strong data management skills and attention to detail
Ability to handle competing demands with diplomacy and enthusiasm
Ability to work collaboratively with faculty and divisional clinical research infrastructure
Excellent time management and ability to prioritize work assignments
Ability to read and understand clinical trials protocols preferred
Familiarity with medical terminology/environment
Working knowledge of Good Clinical Practices (GCP)
Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat
Â Â Â Ability to use a computer for extended periods
Cover Letter (required)
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Internal Number: JR10148
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