Clinical Science Research Program Managers perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Research Program Managers may also assist with epidemiological and behavioral studies and/or outcomes research and health services research. Clinical Science Research Program Managers either act as work/team leads for 2 or more FTE Professionals, operate as Clinical Research Nurses (RN), or are the subject matter experts (SME) in a particular area. SMEs possess a deep knowledge and oversight of a specific process, function and/or technology. SMEs are considered an authority in the area and are educated on the subject and are also able to share their knowledge with other stakeholders. Some Assignments will not move beyond this level.
Lead and direct the day-to-day operations of clinical trials and studies
Perform as well as responsible for training all coordinators, students and research residents for multiple hospital locations (UCH, HRH and CHCO) in the following:
Collecting study subject’s medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
Performing informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
Interviewing prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
Scheduling subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
Collecting, coding, and analyzing data obtained from research in an accurate and timely manner
Adhere to research regulatory standards
Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
Ensure that the necessary supplies and equipment for studies are in stock and in working order
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
Creation and implementation of processes and procedures and quality improvement initiatives
Act as a Primary Coordinator on multiple trials/studies
Lead the development, implementation, and continuous improvement developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs) that meet the requirements of study protocols, and research regulations and best practices (e.g., ICH guidelines, FDA code of Federal Regulations, and Good Clinical Practice (GCP)). Examples of this include proactively preventing deviations, creating source documents, creating backup plans, and ensuring principal investigator oversight.
Identify, analyze, and lead improvements in operational workflows to enhance efficiency, data quality, and regulatory compliance; communicate findings and strategic recommendations to leadership
Lead feasibility assessments and develop data-driven recruitment and retention strategies; design, implement, and evaluate innovative approaches to optimize study enrollment and participant engagement
Serve as lead in study initiation and close out duties
Oversee and provide leadership to the team members, including managing day-to-day priorities, evaluating and redistributing workloads on a temporary basis, and mentoring staff across multiple sites and hospitals (UCH, HRH and CHCO)
Provide input and feedback to leadership on team members’ overall performance, performance evaluations, opportunities for development, and process improvement initiatives
Complete annual performance reviews on all clinical research staff in the division
Identify training and development opportunities for new and existing team members
Act as a Subject Matter Expert (SME) and authority in the area(s) of clinical research.
Develop and manage study budgets, ensuring financial feasibility, appropriate cost recovery, and alignment with institutional billing compliance and sponsor requirements
Coordinate clinical research visits and collecting/recording data. This position includes comprehensive direct patient contact with a high-level of ethics and integrity.
Collect information to determine feasibility, recruitment, and retention strategies. Employ, evaluate, and assist with the implementation of innovative solutions to maximize recruitment and retention.
Coordinate and manage IRB submissions for study protocols, including initial applications, amendments, and reportable events, ensuring compliance with institutional and federal requirements
Data and Database Management
Review research proposal submission for the division.
Conduct literature reviews for investigators.
Collect, code, and analyze data obtained from research in an accurate and timely manner.
Open and maintain study protocols in OnCore.
Data entry, survey creation, and organization, and retrieval of data for research projects in REDCap and OnCore.
Designing and execution of research projects and analysis of data
Lead project planning, data interpretation and team presentations
Serve as a resource and participate in study initiation and close out duties.
