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Manager of Clinical Research Nursing Operations
2 months ago
The Manager of Clinical Research Nursing Operations will oversee and facilitate research initiatives in collaboration with Investigator Physicians within the Bangor Region Chamber of Commerce's healthcare facilities.
This role ensures adherence to study protocols, good clinical practices, and compliance with federal regulations, as well as organizational policies by supervising the clinical research support personnel involved in clinical protocol activities.
The position is pivotal in ensuring excellence in the design, planning, delivery, and evaluation of clinical research initiatives.Regular monitoring of research documentation for accuracy, completeness, and timeliness is essential, along with providing guidance and support to team members as necessary.
Acts as the primary liaison for the interdisciplinary team concerning daily operations specific to clinical trials.Key Responsibilities:
- Manage and oversee the policies, practices, and procedures of both licensed and unlicensed staff within the designated team.
- Establish the necessary infrastructure for conducting clinical trials by assessing clinical, physical, technological, and staffing resources to ensure compliance with study protocols and regulations while prioritizing participant safety.
- Assign nursing and research support personnel to specific clinical trials related to various disease teams.- Recruit, train, supervise, and evaluate staff, providing direction and support on a range of research topics, including Informed Consent, subject enrollment, data management, and study monitoring/auditing.
- Collaborate with Principal Investigators on the assessment and execution of complex trials for the research team.- Identify accrual targets, study activation timelines, and metrics, while addressing potential discrepancies or barriers to enrollment prior to study initiation.
- Oversee protocol adherence and ensure that research site personnel and investigators conduct studies in accordance with protocols and Good Clinical Practice guidelines.
- Stay informed on federal and state regulations for new guidance, updates, or policies.- Maintain a high level of knowledge regarding these requirements to ensure organizational compliance with review and reporting obligations.
- Coordinate, oversee, and participate in various meetings, including Pre-study Visits, Site Initiation Visits, Monitoring visits, Multi-disciplinary Team meetings, and staff meetings.
- Supervise the Pediatric Oncology Research Program.Additional Information:
- Exceptional clinical, organizational, and supervisory skills, with a proven ability to effectively collaborate across interdisciplinary teams to achieve organizational objectives.
- Strong capability to communicate clearly, both orally and in writing, to ensure the safety of clinical trial participants. - Demonstrated clinical and analytical skills. - Proven experience in evaluating and assessing subjects' eligibility for studies, obtaining informed consent, and coordinating patient enrollment. - In-depth knowledge of Good Clinical Practice guidelines and experience interpreting federal, state, and organizational policies and regulations.- Ability to manage multiple projects simultaneously while balancing competing priorities and deadlines. - Flexibility in work focus, with the ability to transition among various projects without adverse effects.
- Proven ability to report on project deliverables and prepare updates for stakeholders.
Credentials Required: Registered Nurse
Education Required: Bachelor's Degree in a relevant academic or scientific field, along with a minimum of 4 years of experience in clinical trials research or an equivalent combination of education and experience.
