Clinical Trials Director
4 days ago
The Director of Clinical Trials Office is responsible for the design, preparation, planning, implementation, and review of clinical trials for Colleges and Schools throughout Augusta University. This position will support both grant and commercially-funded sponsored and investigator-initiated clinical studies while ensuring adherence to institutional, local, federal, state, and institutional ethical standards.
Responsibilities- Manage the startup activities of clinical trials, including contract negotiations and planning.
- Coordinate the study, including management of staff, including nurses, research associates, research assistants, etc.
- Oversee contract negotiations, manage executed contracts, and ensure that deliverables are executed in a timely and professional manner.
- Coordinate all clinical research operations with other offices.
- Develop key performance indicators.
- Provide Clinical Care & Conduct Study Visits: Schedule and conduct study visits, including but not limited to coordination of visit, obtain vital signs, concomitant medicine review, administration of study agents, obtaining specimen storage and/or shipment, preparation for future patient visits, and coordination of monitor visits.
- Personnel Management: Coordinate and integrate activities under the control of CTO Managers. Provide oversight and management of Clinical Trials Office staff. Complete yearly reviews and oversight for the management of the core staff. Provide appropriate coaching, counseling, hiring, or termination of employees as required.
- Process Improvements and Metrics: Maintain systems that log, track, and report the status of agreements, contracts, IRB reports/approvals/continuations, FDA reports, and other applicable reports and ensures compliance with meeting deadlines and expiry dates. Develop systems to identify the needs of investigators, develop external relationships with drug companies, device companies, and other research funding sources, and consortium. Identify opportunities for consolidation and reorganization of CTO staff, processes, and systems. Assess clinical research activities and develop short/long term goals/strategic plans, as well as improve efficiency, compliance with regulations, and fiscal integrity of clinical research studies.
Bachelor's degree from an accredited college or university with a minimum of seven years of progressively responsible experience in an academic or research setting, including experience in a clinical trials office or clinical trials administration. OR Registered Nurse with a minimum of five years of progressively responsible experience in an academic or research setting, including experience in a clinical trials office or clinical trials administration.
Proficient in Microsoft Office and other computer software/databases with the ability to learn and master new programs and other related software as needed. Team leader with strong history of change management and process improvement. Working knowledge of FDA, GCP, IRB policies; Clinical Trial industry including negotiations with CRO and pharma companies; and clinical trial budget budgeting principles, forecasting, billing, and management of contract deliverables, etc.
Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong organizational, multi-tasking, customer service, judgement, problem solving, and time management skills with the ability to foster these skills in employees and within the CTO.
Ability to maintain confidentiality. Ability to display a willingness to work with other members of the organization. Ability to interpret, convey, explain, and uphold regulatory and institutional requirements. Strategic thinker with the ability to manage multiple projects and initiatives, both collaboratively and independently. Responsible leader with ability to foster growth and development of employees, empowering them to implement improvements and change.
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Clinical Trials Director
2 weeks ago
Augusta, Maine, United States InsideHigherEd Full timeJob SummaryThe Director of Clinical Trials Office will be responsible for the design, preparation, planning, implementation, and review of clinical trials for Colleges and Schools throughout Augusta University. This includes managing the startup activities of clinical trials, coordinating the study, and overseeing contract negotiations. The successful...
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Clinical Trials Director
2 weeks ago
Augusta, Maine, United States InsideHigherEd Full timeJob SummaryThe Director of Clinical Trials Office is responsible for the design, preparation, planning, implementation, and review of clinical trials for Colleges and Schools throughout Augusta University. This includes managing the startup activities of clinical trials, coordinating the study, and overseeing contract negotiations and management. The...
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Clinical Trials Director
4 weeks ago
Augusta, Maine, United States InsideHigherEd Full timeJob SummaryThe Director of Clinical Trials Office is responsible for the design, preparation, planning, implementation, and review of clinical trials for Colleges and Schools throughout Augusta University. This position will support both grant and commercially-funded sponsored and investigator-initiated clinical studies while ensuring adherence to...
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