In collaboration with the SCC CTU director, provide leadership for the clinical research program for the UH SCC Clinical Trials Unit. (20%) Oversees the organization of the research operations with the proper allocation of resources and adherence to protocol requirements. (20%) Assist the Director, Clinical Trials in regard to specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures.
(10%) Manage the clinical trial processes and ensure that clinical trials are generated, documented and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations. (20%) Oversee and implement program wide projects and provide training efforts for the clinical team member(s). (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) and Master's Degree (Preferred) Work Experience 5+ years of clinical research experience which includes at least 3 years demonstrated management, supervisory or project management experience; (Required) Knowledge, Skills, & Abilities Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively.
(Required proficiency) Strong leadership skills to train and supervise direct reports with effective experience in resource planning. (Required proficiency) Ability to work consistently and effectively as part of a high performance work team. (Required proficiency) Good judgment, initiative and problem solving skills.
(Required proficiency) Excellent written communication skills and interpersonal and verbal communication skills. (Required proficiency) Ability to follow through and consistently demonstrate primary job responsibilities are current. (Required proficiency) Knowledge of computer operations and demonstrated computer skills in a variety of software environments (ie Excel, Access, Word, database applications).
(Required proficiency) Licenses and Certifications Research certification (i.e., SoCRA, ACRP) (Preferred) Physical Demands Standing Occasionally Walking Occasionally Sitting Constantly Lifting Rarely up to 20 lbs Carrying Rarely up to 20 lbs Pushing Rarely up to 20 lbs Pulling Rarely up to 20 lbs Climbing Rarely up to 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%