Clinical Research Manager

General Description: Responsible for overseeing, coordinating and conducting clinical research studies with a sense of urgency while being proactive to improve the quality and efficiency of the overall process. Ensures compliance with up to date Institutional Review Board (IRB) requirements, related laws, regulations, policies, and guidelines.

Core Duties and Responsibilities:

• Responsible for the day-to-day operations of assigned clinical studies, which includes subject recruitment, study conduct and the input of study data and management of timelines for assigned clinical trials
• Ensures the staff is properly trained and up to date in conducting and ensuring compliance with the protocol, federal and institutional requirements.
• In collaboration with LECR Director is responsible for strategic planning in order to meet timelines, along with ensuring all report and study milestones are being met including recruitment targets, data entry timelines, budget and sponsor requirements
• Lead the preparation of all essential study documents including source and data documentation, case report forms, adverse event, and reporting in a timely manner
• Implement and maintain Quality Control procedures for the data input into the databases and reporting from the CTMS
• Ensure proper maintenance and accuracy of the regulatory files to ensure completeness
• Actively participates in any internal and external audits or review of study protocols
• Supports the correspondence, collection of regulatory documents for the IRB submissions and/or other regulatory entities
• Responsible for determining and coordinating the procurement of the operational, material and supply requirements for each study
• Assists in identifying and evaluating third party vendors including the Clinical Trial Management System (CTMS) to continually improve the functionality, efficiency and reporting capabilities
• Collaborates and provides insights in the design, coordination and implementation of all research projects
• Ensure that quality and/or subject safety concerns are recorded and addressed in a timely manner
• Flexibility to travel outside of the facility to recruit potential subjects (i.e., physician offices, health fairs, expos, lecture presentations, etc.)
• Flexibility to work outside traditional business hours for event participation as needed
• Regular onsite attendance is an essential function of this position with participation in scheduled meetings

Position Requirements:

• Bachelor’s degree in a related field; Certification in Clinical Research or equivalent
• At least 5+ (preferably 7+) years’ experience working with clinical trials involving human subjects.
• Supervisory experience and/or demonstrated experience in training others, particularly in the field of clinical research
• Demonstrated ability to recruit, select and enroll subjects, and adhere to approved study protocols
• Ability to utilize a clinical trial management system
• Excellent interpersonal skills, including but not limited to problem-solving, teamwork development, leadership, and mentorship.
• Highly organized and adaptable with the ability to effectively manage multiple priorities and meet the demands of a dynamic work environment.
• Ability to supervise and train research staff
• Having excellent written and verbal communication skills
• Utilizes discretion in handling confidential information
• Working knowledge of Microsoft Office Suite and able to learn clinical research software programs including the clinical trial management system and electronic data capture
• Able to do moderate physical activity with some and/or continuous standing or walking, for example, traveling to and participating in health fairs or giving presentations