- 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 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.
- MINIMUM QUALIFICATIONS:
- Bachelor's degree required; course work in nursing, biology or health sciences preferred.
- Certification with Association of Clinical Research Professionals (ACRP) or CRPC (Clinical Research Professional Certification) with Society of Clinical Research Association (SOCRA) preferred.
- Recent experience in a clinical patient care setting with demonstrated proficiency in medical terminology and EMR navigation required; patient care experience required.
- Clinical research experience, at the site level or within the industry, preferred.
- Colleagues of Saint Alphonsus Health System enjoy competitive compensation with a full benefits package and opportunity for growth throughout SAHS and Trinity Health.
- Visit to learn more about the benefits, culture and career development opportunities available to you at Saint Alphonsus Health System.
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Cardiology Clinical Research Coordinator Full - Boise, United States - Trinity Health
Description
Employment Type:Full timeShift:
Day Shift
Description:
POSITION PURPOSE:
As a Clinical Research Coordinator, you will work on-site to facilitate the implementation and conduct of cardiology clinical research; the Clinical Research Coordinator 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. You will participate in 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. Clinical Research Coordinators will assume responsibility for regulatory management of all study related documents and submissions.
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. **
WHAT YOU WILL DO:
At Saint Alphonsus Health System, we are looking for people who are living out their calling. We want you to be passionate about coming to work, and challenged to achieve your potential. Living by these virtues, we pride ourselves on exceptional service and the highest quality of care.
Visit to learn more about the benefits, culture, and career development opportunities available to you at Saint Alphonsus Health System.
Visit Saint Alphonsus on LinkedIn, Facebook, Instagram, YouTube, and Twitter
Our Commitment to Diversity and Inclusion
Trinity Health is one of the largest not-for-profit, Catholic healthcare systems in the nation. Built on the foundation of our Mission and Core Values, we integrate diversity, equity, and inclusion in all that we do. Our colleagues have different lived experiences, customs, abilities, and talents. Together, we become our best selves. A diverse and inclusive workforce provides the most accessible and equitable care for those we serve. Trinity Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by law.
