Advanced Practice Registered Nurses / Physician Assistants
Hospital, Public and Private
Internal Number: 5506
Northern Light Eastern Maine Medical Center
Department: Cancer Care - Brewer
Position is located: Lafayette Building
Work Type: Full Time
Work Schedule: 8:00 AM to 4:30 PM
The CRN takes ownership and responsibility for the day-to-day management of genomic research trials including but not limited to the MCGI and Tapur trials, through close out.
Participates in the informed consent process of study subjects at all NL EMMC participating sites
Supports the safety of clinical research patients/research participants
Coordinates protocol related research procedures, study visits, and follow-up care with all participating sites
Screens, recruits and enrolls research participants
Maintains study source documents
Reports adverse events
Understands and is compliant with good clinical practice (GCP) and regulatory compliance with CITI training completion
Educates staff at remote NL EMMC participating sites on protocol, study intervention, study drug, etc.
Educates subjects and family on protocol, study intervention, study drug, etc.
Complies with Institutional policies, standard operating procedures (SOPs) and guidelines
Works closely with clinical trials team to identify, implement and successfully conduct cooperative group, industry, and investigator-led clinical trials.
Ensures financial, operational, accrual and other strategic targets are met. Develops and implements corrective action plans as necessary to improve productivity, quality and/or process workflows.
Works closely with physicians and study teams at all participating sitesto ensure efficient and timely implementation of new genomic trials and ensures and maintains ongoing compliance with company policies and procedures, SOPs, ICH/GCP guidelines, and FDA regulations.
Brings oncology research subject matter expertise to the planning and execution of study start-up processes, to include remote NL EMMC participating sites, including:
Medicare Coverage Analysis development (SOC vs NSOC assessments) and study budget negotiations
Study startup operational efficiency and effectiveness
Participates in the development of policies and procedures, and other tools to support the studies with the research manager
May represent the interests of the oncology research program at local/national meetings and educational conferences pertinent to public relations and future business development.
Equal Opportunity Employment:
We are an equal opportunity, affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, disability status, gender, sexual orientation, ancestry, protected veteran status, national origin, genetic information or any other legally protected status.
Qualifications and Skills:
Exceptional organizational and clinical research management skills
Excellent interpersonal skills with the ability to build strong relationships across multiple organizations
Excellent time management, critical thinking, analytical and problem-solving skills
Advanced computer skills, including CTMS, EDC, document management systems, databases and Microsoft Office suite
Experience and Education:
BS degree in life sciences or related research field required (advanced degrees preferred)
RN required, with current OCN or CRA/CRC certification preferred (ACRP or SoCRA)
At Northern Light Health, we’re building a better approach to healthcare because we believe people deserve access to care that works for them. As an integrated health delivery system serving Maine, we’re raising the bar with no-nonsense solutions that are leading the way to a healthier future for our state. Our more than 12,000 team members are committed to making healthcare work for you: our patients, communities, and employees.