Clinical Trials Manager

 Job Summary (Summary of the basic functions of the position)

Under general supervision of the Director of Research, maintain all activities related to the conduct of clinical trials at the site. Oversees team of clinical trial coordinators.

 Duties and Responsibilities (Responsibilities necessary to accomplish job functions)   

• Manage the day-to-day support of complex clinical trials for research sites across the life cycle of the study, including study feasibility, regulatory compliance oversight, coordination of protocol review and approval, study initiation, operation and close out.
• Oversee coordination of clinical trials to ensure studies are completed on time, within budget and in compliance with the clinical trial protocol, standard operating procedures, FDA regulations and ICH/GCP guidelines.
• Consult, advise and meet with investigators for conducting clinical trials and assisting with development of protocols.
• Receive and review invitations for research studies from industry sponsors, investigator-initiated trials (IITs) and Clinical Research Organizations (CRO)
• Collaboration with the Institutional Review Board in ensuring regulatory compliance.
• Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on action items.
• Responsible for staff recruitment; develop, facilitate and support staff onboarding and development, including orientation, staff competencies, and continuing education.
• Ensure that the safety and welfare of human subjects are protected and that legal, privacy, and confidentiality measures are implemented.
• Responsible for the region reaching profitability and revenue goals set by leadership annually.
• Ensure the site is optimizing the schedule and workflows to maximize daily research visits.
• Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on action items.
• Working closely with the Site Director to achieve strategic goals for the site.
• Assist with invoicing and end of month financial reconciliation.
• As needed, manage CTMS study builds, eSource, eReg, user access, and preferences

• Support research visits by completing informed consent discussions, collecting medical history, completing vitals, blood draws, biospecimen processing, and other assessments required per protocol.
• Adheres to all safety policies and procedures in performing job duties and responsibilities while supporting a culture of high quality and great customer service.
• Performs other duties that may be necessary or in the best interest of the organization.

Experience Requirements

• 5+ years of experience in clinical healthcare setting involving operations management, quality data/informatics, and/or healthcare systems implementation and training.
• 3+ years of clinical trial experience, with a strong focus on training delivery and development

Knowledge, Skills and Abilities Requirements

• Experienced in project management, clinical trial management-oversight, site management-monitoring, data management, pharmacovigilance/drug safety, quality management, audits/regulatory agency inspections, and regulatory compliance.
• Meticulously detail oriented, professional attitude, reliable
• Organizational skills to support accurate record-keeping
• Ability to follow verbal & written instructions
• Interpersonal skills to work as a team with patients and outside parties
• Able to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretations
• Mathematical and analytical ability for basic to intermediate problem solving
• Basic to intermediate computer operation
• Proficiency with Microsoft Excel, Word, and Outlook
• Specialty knowledge of systems relating to job function
• Knowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelines

 Supervisory Responsibilities:

• Directly supervises research assistants and clinical trials coordinators.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees, planning, assigning, and directing work; appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.