Coordination and facilitation of the daily operations of reading center studies including the development and implementation of new Reading Center 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). Oversight of program and office coordinators for study and regulatory operatio... more details
Essential Functions
Coordination and facilitation of the daily operations of reading center studies including the development and implementation of new Reading Center 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).
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.
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.).
Audit CIARC/REDIARC perform image and data analysis for federal and corporate clinical research studies as related to natural history, surgical, pharmacologic and device intervention, safety and efficacy studies.
Meet biweekly with external compliance vendor to audit CIARC/REDIARC’s 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.
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.
Supervise training, including orientation for new students, task- and SOP-related training, and regular CIARC/REDIARC staff meetings.
Required For All Jobs
Performs other duties as assigned.
Complies with all policies and standards.
For specific duties and responsibilities, refer to documentation provided by the department during orientation.
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Qualifications Education
Associate's Degree . Required and
In lieu of degree requirements must have 7 or more years of clinical research experience. Required
Work Experience
3 years of clinical research experience Required
Knowledge, Skills, & Abilities
Computer literacy; ability to integrate research findings; data input and word processing Required
Strong oral and written communication skills and interpersonal skills; must demonstrate the ability to effectively and professionally communicate and work with various individuals Required
Strong organization skills; ability to multi-task, prioritize and meet deadlines. Required
Effective problem-solving skills Required
Ability to educate/train staff effectively Required
Knowledge of good clinical practices Required
Clinical research skills and Clinical Trials procedural knowledge and experience Required
Licenses and Certifications
Society of Clinical Research Associates (SoCRA) Certified Clinical Research Professional Required
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