Senior Clinical Project Manager
Provides leadership and training related to all regulatory processes related to clinical research activities
• IRB preparation, submission, modifications, reporting and termination activities
• Structures the maintenance of all regulatory documents
• Leads others in sponsor correspondence, monitoring and study meetings
• Guides interdepartmental auditing of regulator practices
Serves as a resource for facilitating grants, contracts and financial tasks for research and clinical trials
• Independently provides services for investigators in study budgeting, sponsor interactions, routing, feasibility assessments, account management and reconciliation
• Serves as a collaborator and key contact for key business partners.
Responsible for research protocol development, conduct and facilitation at an expert level
• Provides substantial support for investigators in writing study protocols
• Leads participant screening, enrollment, study activities and communication
• Coordinates study visits and procedures including specimen acquisition, transport, documentation and shipment and monitor process for services
• Acquires equipment and supply resources for research studies
Provides leadership for data management activities
• Develops and evaluates source and CRF tools
• Manages data entry and ensures data integrity
• Supports statistical services needs
• Collaborates with Executive Director and/or Principal Investigators to assess data management needs
Serves as an instructor and mentor for quality and education activities
• Monitors compliance throughout all study activities
• Engages compliance oversight as needed
• Maintains all licensure, certification and system education requirements for role
• Coordinates educational activities related to study needs for study staff, investigator team and patient care staff
• Initiates departmental policy and quality projects

Additional Information
Position Type: Employee
Ref Code:

Contact Information
Angela Spangler
spanglea@ohio.edu
Ohio University Heritage College of Osteopathic Medicine
1 Ohio University
Athens, 45701
740-593-2544