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Trinity Health · 13 hours ago

Clinical Research Coordinator Full -Time - Boise

Boise, ID

Full-time

Onsite

Senior Level

5+ years exp

Trinity Health is seeking a Clinical Research Coordinator to join their team in Boise. The role involves facilitating the implementation and conduct of clinical research, ensuring compliance with regulations and maintaining participant safety throughout trials.

DeliveryHealth Care

No H1B

Responsibilities

Meets Health System's Guiding Behaviors and Caring Standards including interpersonal communication and professional conduct expectations

Participates in clinical trial feasibility assessments

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

Develops all applicable consent forms for proposed clinical research trials; maintains oversight and documentation of the informed consent process in accordance with applicable federal regulations, IRB determinations and SAHS legal and institutional requirements

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

Initiates review of protocol eligibility requirements and confirms patient eligibility

Performs case management of study participants

Submits required data to research sponsors and/or their designated representatives; 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

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

Ensures that quality control and quality assurance guidelines are met

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 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

Ability to work independently, balances multiple projects, and meets deadlines

Demonstrate analytical thinking, problem solving and interpersonal skills

Experience using MS Word and Excel, MS Teams and Outlook and EPIC

Qualification

Clinical research experienceRegulatory complianceData managementInformed consent processIRB submissionProject managementAnalytical thinkingDirect patient careMS WordExcelEPICCommunication skillsProblem solvingTeam collaboration

Required

Bachelor's degree including course work in research or applied research methods or equivalent combination of education and experience

Minimum of 5 years in clinical research is required, with an emphasis on prospective, randomized Phase 2-4 trials

Direct patient care experience required

Applicants for this position must be authorized to work for any employer in the U.S. We are unable to sponsor an employment visa for this position

Exceptional administrative, project management, and communication skills

Ability to be self-directed, yet still a contributing member of a larger team

Meets Health System's Guiding Behaviors and Caring Standards including interpersonal communication and professional conduct expectations

Participates in clinical trial feasibility assessments

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