Oversees the administrative functions of single and/or multi-institutional research trials. Coordinates/manages daily organization and operational activities related to Phase I-IV clinical research trials. Facilitates key trial communications between the different participating institutions, sponsors and UH.
(20%) Coordinates development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by IRB, sponsor and FDA. Collect and review regulatory documents from sites. (20%) Track and provide oversight for the start-up and maintenance of trial activities, enrollment, safety issues and protocol adherence at the different participating institutions.
(20%) Oversee and coordinate the clinical trials team (external study coordinators, database manager, researchers and statisticians) responsible for data input, analysis and reporting. (10%) Organize, coordinate and participate in training for the different participating institutions. Develops and maintains planned communication with sites (ie: study progress updates, newsletters, etc) (10%) Assesses investigator and site performance.
(10%) Additional Responsibilities 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. Education Bachelor's Degree (Required) Work Experience 3+ years of clinical trial experience as a study coordinator, project manager, budget or contract research associate or equivalent management experience within the clinical research field.
(Required) Knowledge, Skills, & Abilities Knowledge of FDA regulations, ICH and GCP guidelines and their applications to clinical research trials. (Required proficiency) Excellent interpersonal, organizational and project management skills. (Required proficiency) Excellent problem solving skills.
(Required proficiency) Ability to understand and communicate data requirements to others. (Required proficiency) Demonstrate ability to work with multiple software technologies. (Required proficiency) Licenses and Certifications CITI Training (Required within 90 Days) and SoCRA or ACRP certification (Preferred) Physical Demands Standing Occasionally Walking Occasionally Sitting Constantly Lifting Rarely 20 lbs Carrying Rarely 20 lbs Pushing Rarely 20 lbs Pulling Rarely 20 lbs Climbing Rarely 20 lbs Balancing Rarely Stooping Rarely Kneeling Rarely Crouching Rarely Crawling Rarely Reaching Rarely Handling Occasionally Grasping Occasionally Feeling Rarely Talking Constantly Hearing Constantly Repetitive Motions Frequently Eye/Hand/Foot Coordination Frequently Travel Requirements 10%