Sign on Bonus Eligible
Summary:
The Clinical Research Nurse Manager will be responsible for collaborating and coordinating research activities with Investigator Physicians at Eastern Maine Medical Center Cancer Care ambulatory and in-patient units. Ensures protocol compliance, good clinical practice and adherence to federal regulations, Eastern Maine Medical Center policies, and Clinical Trial Office SOPs by supervising the clinical research support staff in the conduct of clinical protocol activities. Ensures excellence in the design, plan delivery and evaluation for implementation of clinical research at EMMC. Routinely monitors research charts for accurate, complete, and timely data and provides coaching and counseling to direct reports as needed. Serves as the central point of contact for the interdisciplinary team related to day-to-day clinical trial specific operations.
Responsibilities:
- Manages and monitors policies, practices and procedures of licensed and unlicensed staff in their assigned working group.
- Ensure infrastructure to conduct clinical trials by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies and regulation while ensuring participant safety. Includes assigning nursing and research support staff to the disease team specific clinical trials.
- Hires, trains, supervises and evaluates staff providing direction, training, support on a variety of research topics, including but not limited to: Informed Consent, enrolling study subjects, data management and monitoring/auditing of studies.
- Collaborate with Principal Investigator (PI) on assessment and implementation of highly complex trials for the research team. Includes identifying accrual targets, study activation timelines and metrics and resolving potential discrepancies and/or barriers to enrollment by prior to study activation.
- Manage oversight of protocol conduct and ensure that research site personnel and investigators, are conducting the study according to the protocols and Good Clinical Practice guidelines.
- Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure organizational compliance with congruency review and reporting requirements.
- Coordinates, oversees and participates in meetings including but not limited to Pre-study Visits, Site Initiation Visits, Monitoring visits, Multi-disciplinary Team meetings, staff meetings.
- Oversees Pediatric Oncology Research Program.
Other Information:
- Excellent clinical, organizational, and supervisory skills, with proven ability to successfully facilitate work across interdisciplinary teams to accomplish organizational goals.
- Ability to comprehend and provide clear oral and written communication to safeguard the safety of clinical trial participants. Strong clinical and analytical skills. Proven ability to evaluate and assess subject’s suitability for inclusion into studies, obtain informed consent, determine patient eligibility and coordinate patient enrollment.
- Strong knowledge of Good Clinical Practice guidelines. Proven experience interpreting federal, state, University and sponsor policies and regulations. Experience with interpreting complex oncology clinical trial protocols and federal, state, local guidelines.
- Proven ability to manage several projects concurrently, while balancing competing priorities and deadlines. Extreme flexibility in work focus; ability to switch among several different projects without any adverse effects.
- Demonstrated ability to report on the status of project deliverables and draft and submit project updates to Yale team and study sponsor.
Credentials
- Required Registered Nurse
Education
- Required Bachelor's Degree - Bachelor’s degree in a relevant academic/scientific field
- Minimum of 4 years of experience in clinical trials research or the equivalent combination of education or experience.
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