Clinical Research Coordinator Full -Time - Boise

Trinity Health • Boise, ID

3d • Onsite

About The Position

We are looking for a Clinical Research Coordinator to join our team in Boise! POSITION PURPOSE: As a Clinical Research Coordinator, you will work on-site to facilitate the implementation and conduct of clinical research. You 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, participating 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. You will assume responsibility for regulatory management of all study related documents and submissions as applicable to the nature and complexity of the proposed trial. Our ideal candidate will have exceptional administrative, project management, and communication skills with an ability to be self-directed, yet still a contributing member of larger team. 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.

Requirements

• 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.

Nice To Haves

• Certification with Association of Clinical Research Professionals (ACRP) or CRPC (Clinical Research Professional Certification) with Society of Clinical Research Association (SOCRA) preferred.

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.

Benefits

• Colleagues of Saint Alphonsus Health System enjoy competitive compensation with a full benefits package and opportunity for growth throughout SAHS and Trinity Health.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees