The Clinical Studies Supervisor participates in the management of departmental clinical research activities and staff. Participates in protocol-specific clinical tasks and assists the primary investigator in collection and evaluation of data. Works with Research Nurse Manager to assign protocols to staff and monitors accuracy compliance of staff. Coordinates and participates in the interview and selection process and evaluates staff. Participates in the training and development of staff and designs and facilitates educational sessions.
JOB SPECIFIC COMPETENCIES
Clinical Protocol Operations
• Provide overall coordination and facilitation of research protocol operations
• Provide overall support to PI and other research staff as assigned in the development of new protocols and protocol amendments.
• Collect and develops criteria information for protocol submissions
• Develop and maintains a processing and tracking system for all protocol related paperwork
• Provide assistance with the development of SOP's and a Quality Assurance program for the department.
• Provide assistance with achieving clinical research activities goals for area of responsibility and offers suggestions/recommendations regarding program operations with the goal of creating efficiencies.
Clinical Protocol Activities
• Coordinate the effective operation of multiple clinical research projects and assigns to appropriate staff activities related to initiation and conduct of clinical trials.
• Manage SMO protocol-specific clinical tasks
• Utilizes strong interpersonal skills to communicate with a variety of healthcare individuals
• Compile protocol data
• Oversee staff and workflow of projects and activities associated with research protocol operations
• Oversee protocol-related research activity of protocol operations, to ensure compliance to all standards, policies, and quality measures.
• Oversee activities of clinical trials personnel to provide guidance, correction when needed, and coverage when short-staffed.
• Coordinate and participate in the interview and selection process for clinical research personnel in assigned area.
• Coordinates personnel issues and actions, including evaluation and productivity, performance and training needs of assigned staff.
• Provide training and mentoring for new studies and clinical studies coordinators for protocol related activities which involves steps to follow for compliance of institutional as well as human subject research federal guidelines.
• Participate in management of departmental clinical research activities and assigned personnel, with emphasis on effective utilization of resources.
• Communicate and administer departmental and institutional policy and procedures for personnel in the clinical research area.
• Identify needs and provide training and guidance with regard to the policies and procedures that are related to management and monitoring of patients on clinical trials, as delineated in the department training manual and presented at weekly training meetings.
• Participate in the training and development of personnel in the clinical research area, with emphasis on effective orientation and continuing education.
• Plan, design, and conduct complex staff education and disseminate information by means of the weekly training sessions/presentations and/or written communications. Participate in conducting department training sessions to insure protocol compliance and dissemination of new information and policies.
• Mentor and encourage clinical research staff to develop through participation in professional organizations, serving on committees, attending journal presentations, seminars, or conferences.
• Attends appropriate departmental meetings and institutional continuing education programs.
• Shares information and, as requested by supervisor, develops educational presentations for the monthly Clinical Research Group Meeting.
• Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process, including but not limited to eligibility and disease processes.
• Planning, designing, and conducting complex professional and ancillary education sessions to ensure dissemination of new information and policies.
• Assists in the regulatory audit as needed.
Other duties as assigned
Required: Bachelor's degree.
Preferred: Master's Level Degree
Required: Six years' experience with research studies or direct patient care obtained from nursing, data gathering or related field to include three years in a lead or supervisory capacity. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience to include three years of lead or supervisory experience. Successful completion of the LEADing Self Accelerate program may substitute for one year of required supervisory or management experience.
Preferred: Oncology registered nurse experience.
Preferred: Certified Clinical Research Professional (CCRP)
State of Texas professional nursing license (RN) and/or current CPR, BLS, or ACLS certification.
Onsite Presence: Is Required