Clinical Research Nurse Coordinator

Northern Light Mercy Hospital | Portland, ME, United States

Posted Date 11/30/2021
Description


Northern Light Mercy Hospital

Department: Cancer Care

Position is located: Mercy Medical Office Building

Work Type: Full-time

Hours: 32 hr/wk

RN's with a minimum of two years of oncology experience are eligible for a $10,000 sign on bonus paid out in four installments.

Relocation available for those who meet criteria.

*current employees at any Northern Light Health Members or former employees with a service break less than one year are not eligible for relocation/sign on bonus.

Summary:
Northern Light Mercy Hospital is seeking an experienced, ambitious, and enthusiastic Clinical Research Nurse Coordinator (CRN) to develop and grow the Cancer Clinical Research Program. The ideal candidate will be a self-starter working in collaboration with multi-disciplinary groups in the care of patients treated within the Cancer and Hematology Clinical Research Program and will oversee all research treatment plans, toxicities, symptom management, and adherence to protocols. This person will be responsible for coordinating clinical research studies including but not limited to recruitment of participants, follow-up, data management, submission of protocols with subsequent amendments, detailed record keeping, regulatory compliance, report writing & correspondence with investigators, IRBs, and regulatory authorities. The CRN attends patient conferences to provide input relating to trial availability and specifics. Provides education to study patients and their families throughout study participation. Serves as a liaison between investigators, research personnel, clinical teams, outside study personnel and IRB’s to assist in protocol interpretation, patient eligibility criteria, enrollment, and safety questions. The Clinical Research Nurse Coordinator is a great opportunity for an individual who enjoys working with patients and possess excellent analytic, interpersonal and communication skills, and can work independently as well as part of a multidisciplinary team.

Responsibilities:
The CRN takes ownership and responsibility for the day-to-day management of research trials through close out. Participates in the informed consent process of study subjects at NL Mercy 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 and affiliates. Patient accrual: screens new patients daily -determines preliminary eligibility- informs physician- follows through with patients for possible entry into clinical trial. Collaborates with physicians, nursing staff, pharmacy , accounting to ensure that protocol registration-enrollment procedures are followed : current consent obtained, pre-study tests reported, final eligibility determined, investigational drugs on hand or plan to order; all protocol supplies on hand and appropriate billing is arranged (per Mercy Hospital and federal guidelines). 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 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. Works closely with physicians and study teams 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. Participates in study start-up processes, to include - study feasibility, - Medicare Coverage Analysis development (SOC vs NSOC assessments) and study budget negotiations. Participates in the development of policies and procedures, and other tools to support clinical research, may represent the interests of the oncology research program at local/national meetings and educational conferences pertinent to community outreach and future business development.

Qualifications and Skills: Must be detail-oriented with the ability to work on multiple projects simultaneously; Demonstrated skills in critical thinking, problem solving, and ability to make independent decisions. Strong Interpersonal and communication skills to interact effectively with patients, families and other healthcare providers, ability to collaborate with multiple disciplines and departments, thorough knowledge of theory, practice, principles, processes, and issues of nursing usually acquired through 2-3 years of clinical experience. Advanced computer skills, including, Electronic Data Capture, & document management, databases, and Microsoft Office suite.

Experience and Education: Maine RN License required. BS degree in life sciences or related research field required (advanced degrees preferred). Minimum of 2-3 years of clinical experience. 1-2 yrs. Oncology and/or Clinical Trials Research Experience Preferred, Current OCN or CRA/CRC certification preferred (ACRP or SoCRA).
Human Subjects Protections and Good Clinical Practice training and Clinical Research Coordinator course within 3 months of hire if not already attained.
Additional CITI Courses required after hire.


Working conditions:
Essential:
* Potential exposure to abusive and/or aggressive people.
* Work with computers, typing, reading or writing.
* Lifting, moving and loading 20 to 30 pounds.
* Continuous sitting.

Job Type
Regular
Industry
Healthcare | Science - Research

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