Job Description:

The Clinical Research Supervisor provides clinical research expertise by participating in the design and implementation of research projects and the care of research patients.  This position is responsible for organizing and coordinating research staff in order to ensure departmental effectiveness and efficiency in the conduct of clinical research activities and for the development of research infrastructure, coordinating projects, and communicating status and improvement areas to leadership;  implementing and coordinating department-wide initiatives such as research quality management or clinical trial recruitment efforts; ensuring compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB); collaborating with the Director of Research and Principal Investigators and other managerial staff to  plan and coordinate strategies for improving efficiency, implement action plans to improve quality, and conduct training and education of personnel.
 
Primary Duties and Responsibilities:
•    Provides day to day oversight of regulatory coordinators, clinical research associates, clinical research associates and research nurses.
•    Works with other supervisory personnel to supervise research, clinic, infusion, laboratory and imaging staff as their work relates to research.
•    Monitors research projects through all phases and all departments and participates in weekly research meeting.
•    Assists in the development, review, and revision of standard operating policies and procedures in collaboration with research management personnel.
•    Participates in audit preparation and organizes staff to participate.  Prepares for institutional, pharmaceutical and internal audits, including facilitating third party study monitoring.
•    Provides clinical research expertise by participating in the design and implementation of research projects and care of research patients as needed by the department or institution. Implements and coordinates department-wide initiatives such as research quality management.
•    Participates in biweekly research management meetings under the direction of the Director of Research Program. Meets with direct reports weekly to assure timely and accurate compliance with research study protocols
•    Compiles and distributes the weekly research update to include patients in consideration and screening, and to communicate and coordinate needed biopsies with the imaging department as well as the infusions with the infusion supervisor.
•    Acts as a liaison with Principal Investigators, pharmaceutical company representatives and other project funding organizations to monitor and update project progress. Serves as an internal consultant for specific departmental activities.
•    Provides clinical expertise and support with quality assurance, performance improvement, and health plan compliance for clinical trial compliance.
•    Responsible for insuring timely submission of complete, accurate and neat documents to research sponsors, IRB, and contract research organizations, where applicable.
•    Attends site feasibility visits and site initiation visits for potential studies, and assures that new studies are implemented according to protocol.
•    Assists with clinical procedures, providing related patient care when required
 

Educational Requirements:

• Bachelor's Degree- Science or Health Care field preferred
• Master's Degree- MS/MA/MPH in related field preferred

Licenses:

• CITI Course Certification preferred
• Certification In Clinical Research preferred
• Basic Life Support (BLS)- If in patient facing role, Certification is preferred

Experience:

• 2 years- Experience in Research and supervising staff
• 3 years- Knowledge of IRB clinical research application procedures
• 6 months- Experience in Pharmaceutical/Biotechnology, or Contract Research Organization (CRO)
• 6 months- Experience in Phase I, II, III clinical trials in oncology

Physical Demands:

Standing, Walking, Sitting, Lifting - 50 lbs., Carrying - 50 lbs., Pushing - 50 lbs., Pulling - 50 lbs., Climbing, Balancing, Stooping, Eye/Hand/Foot Coordination, Crouching, Crawling, Reaching, Handling, Grasping, Feeling, Talking, Hearing, Repetitive Motions, Kneeling