Clinical Research Nurse - Cancer Research

Northern Light Eastern Maine Medical Center

Department: Cancer Research

Position is located: Lafayette Building, Brewer, ME

Work Type: Full Time

Hours Per Week: 36 Hour/Week

Work Schedule: 7:30 AM to 5:00 PM

Eligible for Sign on Bonus

Summary :

The Clinical Research Nurse is responsibility for the day-to-day management of research trials through close out. Participates in the informed consent process of study subjects at all NL EMMC participating sites. They support the safety of clinical research patients/research participants. They coordinate protocol related research procedures and maintain study source documents. They report to the Manager of Oncology Research.

Responsibilities :

Participates in the informed consent process of study subjects at all NL EMMC participating sites to include screening all new patients daily -determines preliminary eligibility- informs physician- follows through with patients for possible entry into clinical trial.

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 sites to 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:

- study feasibility,

- 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.

Other Information :

• BLS Required.
• 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

Competencies and Skills

• Behaves with Integrity and Builds Trust: Acts consistently in line with the core values, commitments and rules of conduct. Leads by example and tells the truth. Does what they say they will, when and how they say they will, or communicates an alternate plan.
• Cultivates Respect: Treats others fairly, embraces and values differences, and contributes to a culture of diversity, inclusion, empowerment and cooperation.
• Fosters Accountability: Creates and participates in a work environment where people hold themselves and others accountable for processes, results and behaviors. Takes appropriate ownership not only of successes but also mistakes and works to correct them in a timely manner. Demonstrates understanding that we all work as a team and the quality and timeliness of work impacts everyone involved.
• Practices Compassion: Exhibits genuine care for people and is available and ready to help; displays a deep awareness of and strong willingness to relieve the suffering of others.

Credentials

• Required Registered - with current OCN or CRA/CRC certification preferred (ACRP or SoCRA)

Education

• Bachelor's degree required. BS degree in life sciences or related research field required (advanced degrees preferred)

Working Conditions

• Need to drive to perform responsible duties.
• Work with computers, typing, reading or writing.
• Prolonged periods of sitting.