Employment Type:

Full time

Shift:

Day Shift

Description:

We are looking for a Clinical Research Coordinator to join our team in Boise in support of Oncology research!

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. *

WHAT YOU WILL DO:

• 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.

MINIMUM QUALIFICATIONS:

Education/Experience:

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

Credentials/Licensure

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

Related Experience:

• Recent experience in a clinical patient care setting with demonstrated proficiency in medical terminology and EMR navigation required.

• Direct patient care experience required.

• Clinical research experience, at the site level or within the industry, preferred.

POSITION HIGHLIGHTS AND BENEFITS:

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

• Visit www.saintalphonsus.org/careers to learn more about the benefits, culture and career development opportunities available to you at Saint Alphonsus Health System.

MINISTRY/FACILITY INFORMATION:

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 www.saintalphonsus.org/careers (https://www.saintalphonsus.org/careers/search-openings/details?j=00137722_Speech%20Therapist%20PRN) to learn more about the benefits, culture, and career development opportunities available to you at Saint Alphonsus Health System.

Visit Saint Alphonsus on LinkedIn (https://www.linkedin.com/company/saint-alphonsus-health-system/) , Facebook (https://www.facebook.com/SaintAlphonsus/) , Instagram (https://instagram.com/saintalphonsus?utm_source=ig_profile_share&igshid=1ecujfk63xezr) , YouTube (https://www.youtube.com/channel/UCFgYXHlHzYPLDjozyU03WGA) , and Twitter (https://twitter.com/SaintAlsHealth) !

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.

Our Commitment to Diversity and Inclusion

Trinity Health is a family of 115,000 colleagues and nearly 26,000 physicians and clinicians across 25 states. Because we serve diverse populations, our colleagues are trained to recognize the cultural beliefs, values, traditions, language preferences, and health practices of the communities that we serve and to apply that knowledge to produce positive health outcomes. We also recognize that each of us has a different way of thinking and perceiving our world and that these differences often lead to innovative solutions.

Our dedication to diversity includes a unified workforce (through training and education, recruitment, retention, and development), commitment and accountability, communication, community partnerships, and supplier diversity.

EOE including disability/veteran