Director - Clinical Trials Office

Description

Position Summary:

The MaineHealth Institute for Research (MHIR), established in 1991, has experienced remarkable growth, driven by successful grant funding and the recruitment of world-class scientists. The institute's full service scientific facilities foster innovative research with a particular focus on basic, translational science, population health, and clinical trials. As a part of MaineHealth, the state's largest integrated healthcare system, MHIR collaborates with the network of nine hospitals to enable a seamless connection between scientific discoveries and their real-world application in patient care and community engagement. MHIR has state-of-the-art resources to support basic, translational. clinical research, and clinical trials.

MHIR is strategically expanding to enhance its success in biomedical and health research. To support this expansion, we are actively seeking a Director - Clinical Trials Office. Applications will be reviewed on a rolling basis until the position is filled.

The Clinical Trials Office Director reports to the Vice President for Research at MaineHealth. The Director is responsible for the development, promotion, and leadership of the Clinical Trials Office (CTO). They will support the growth of clinical research across the MaineHealth network of hospitals and outpatient clinics in collaboration with other MaineHealth Institute for Research departments by developing and by implementing innovative programmatic, strategic, and operational approaches to advance the quality and efficiency of clinical research. The Director is responsible for the oversight of all clinical trials performed across MaineHealth.

Key knowledge, skills, and abilities: Ph.D. or Master's degree in relevant discipline preferred, Bachelor's degree required; five or more years in a clinical or healthcare environment (preferably in an academic or clinical research non-profit setting); demonstrated thorough understanding of federal regulations governing human subjects' research and regulatory procedures for GCPs; demonstrated excellent leadership and communication skills, including public speaking to facilitate training sessions, lead discussion groups, and deliver presentations; documented skill and experience in management of personnel, including oversight of personnel and professional development; clinical research finance and non-profit grant management experience.

Key responsibilities:

* Lead the CTO in fulfilling its' mission of providing high quality management of innovative clinical trials throughout MaineHealth.

* Lead collaborative efforts to refine, develop and expand services offered by the CTO.

* Provide operational leadership for management, growth, and integration of MaineHealth clinical trials programs.

* Develop, review, and update appropriate guidelines and operating procedures for all Clinical Trials Office activities, ensuring compliance with all required federal, state and institutional policies.

* Participates in the development and execution of annual operating and capital budgets.

* Oversee staff who provide oversight of clinical trials including review of protocols, budgets and contracts.

* Ensure the supervision and professional development of the CTO staff.

* Ensure adequate resources are available to meet study needs.

* Promote a collaborative working relationship with the diverse groups of CTO staff located across the MaineHealth network.

* Promote a collaborative working relationship with other departments within MaineHealth that support clinical research.

* Maintain and promote effective working relationships with Sponsors, Contract Research Organizations, Collaborating Institutions, Principal Investigators, Research Coordinators, and research teams across MaineHealth.

* Responsible for providing assistance and support of research at Maine Medical Center

* Provide an orientation and mentoring program for new Clinical Research Coordinators (CRC).

* Provide assistance and guidance to Investigators and research staff with the coordination and management of their clinical trials.

* Promote adherence to Institutional SOPs, Good Clinical Practice and federal regulations

* Works closely with the Directors of the Office Research Ethic and Compliance, Sponsored Research Grants, MHIR Center Directors, and other leaders to support and grow research at MaineHealth.

* Works collaboratively to address simple and complex problems arising in the clinical trials. space across MaineHealth.

* Metrics and Data: (Information Management)

* Develops and oversees the management of systems, processes and tools to provide Clinical Trials metrics.

* Promote a Culture of Safety * Identify risks and hazards to patients and document mitigation efforts (i.e. monitoring safety events and completing action items, RCAs, and intensive reviews).

* Set targets and take steps to improve hand hygiene compliance.

A hybrid work schedule from our Scarborough, Maine location is available for this position.

The MaineHealth application, a cover letter and a resume or CV are all required elements for application to this position.

Learn more about the MaineHealth Institute for Research in this short video!

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