Clinical Research Nurse

Trinity Health•Boise, ID

1d•Onsite

About The Position

Under the general direction of the Research Administrator, the Clinical Research Nurse facilitates the implementation and conduct of clinical research lead by a designated Principal Investigator at Saint Alphonsus Health Center. Will act as a liaison between physicians and providers, involved staff, patients, the clinical research team and/or trial sponsor to ensure regulatory and institutional compliance and maintenance of human subject protections throughout the continuum of the research. Will participate in a variety of complex activities involving clinical trial implementation, participant recruitment and retention, consent form development and process oversight, data management, ongoing participant safety assessment and all applicable reporting for the duration of trial. Will assume responsibility for regulatory management of all study related documents and submissions as applicable to the nature and complexity of the proposed trial. Requires clinical patient care experience, phlebotomy proficiency, and clinical decision-making skills within the scope of nursing practice and licensure. Additionally, exceptional administrative, project management, and communication skills with an ability to be self-directed, yet still a contributing member of larger team are necessary. Provides an environment that fosters a welcoming center for patient care and builds trust and loyalty among patients, providers, and staff.

Requirements

A current RN license is required.
Multistate licenses must establish residency with the Idaho Board of Nursing within 60 days from hire.
All colleagues must provide licensure or proof of application in process for an Oregon RN license within 90 days of the hire date.
Clinical patient care experience
Phlebotomy proficiency
Clinical decision-making skills within the scope of nursing practice and licensure.
Exceptional administrative, project management, and communication skills
Ability to be self-directed, yet still a contributing member of larger team
Experience using MS Word and Excel, MS Teams and Outlook and EPIC.

Nice To Haves

BSN strongly preferred.
Certification with Association of Clinical Research Professionals (ACRP) or CRPC (Clinical Research Professional Certification) with Society of Clinical Research Association (SOCRA) preferred.
Clinical research experience, at the site level or within the industry, preferred.

Responsibilities

Meets Health System's Guiding Behaviors and Caring Standards including interpersonal communication and professional conduct expectations.
Participates in clinical trial feasibility assessments, giving insight and feedback related to all operational aspects of potential trial implementation.
Contributes/Leads the study start up process including coordination of required trainings, contribution to budget evaluation, document management, engagement of involved service lines (internal and external) and submission of all applicable requests for approval in manner that supports open communication, teamwork and timely implementation of the trial at the site.
Provides direct patient care consistent with protocol requirements, procedures for research participants that is within the standards of nursing practice.
Demonstrated proficiency in clinical nursing skills and willingness to support clinical research coordinators in these areas when needed.
Develops all applicable consent forms for proposed clinical research trials, in consideration of regulatory requirements for the informed consent document and process, as well as the provided template and SAHC standards and ERDs.
Maintains oversight and documentation of the informed consent process in accordance with applicable federal regulations, IRB determinations and SAHS legal and institutional requirements.
Maintains a working knowledge of applicable Federal, State, and local laws and regulations, Trinity Health’s Organizational Integrity Program, Standards of Conduct, as well as other policies and procedures to ensure adherence in a manner that reflects honest, ethical, and professional behavior.
Supports revenue management by accurately documenting services and following departmental guidelines and expectations that ensure compliance with research billing review practices.
Coordinates IRB submission of all proposed research and ensures there is documented IRB approval for the duration of the research at SAHC, including initial and annual review, amendments, unanticipated problems and other of all clinical research studies per federal guidelines and submits revisions, adverse events, and memos on an ongoing basis.
Initiates review of protocol eligibility requirements and in consultation with the Principal Investigator confirms patient eligibility for participation in the research.
Performs case management of study participants who are involved in clinical research trials.
Submits required data to research sponsors and/or their designated representatives through established pathways and in accordance with data submission timelines defined within the protocol and the clinical trial agreement.
Maintains source documentation to support all data submitted to research databases.
Obtains data from external physicians and institutions when necessary for clinical research purposes and utilizes appropriate record request and HIPAA authorization process as needed.
Reports adverse drug reactions according to clinical research study procedures and in adherence to federal regulations and institutional policy.
Performs data submission consistency checks, edits for errors and monitors timeliness.
Participates in and contributes to Research department staff meetings and huddles.
Acts as a liaison between institutional investigators (physicians), Operations Offices and Statistical Centers.
Maintains cooperative relationships with partnering surgical, medical, radiology, and pathology departments as well as other disciplines and team members.
Maintains a system for organizing, planning, and managing clinical research workflow.
Ensures that quality control and quality assurance guidelines are met.
Educates other healthcare professionals, patients, and families regarding clinical research.
Collaborates with the EPIC TC team to ensure order sets are developed prior to study implementation and as applicable, for clinical trials involving administration of an investigational product.
Assumes responsibility, or appropriate delegation of responsibility, for investigational product accountability for research protocol purposes and maintains all product related shipment, storage, receipt and dispensing records.
Prepares and participates in monitoring visits and clinical research study audits and provides a timely resolution to findings and queries.
Ability to work independently, balances multiple projects, and meets deadlines.
Strong sense of teamwork and eager to assist with unique projects and interdepartmental needs when appropriate.
Demonstrate analytical thinking, problem solving and interpersonal skills.