Employment Type:

Full time

Shift:

Day Shift

Description:

Do you have hands-on experience working with Oncology patients and have experience in clinical research or a desire to explore a clinical research role? If so, let's talk!

We are looking for a Clinical Research Coordinator who has:
- hands-on experience working with Oncology patients (REQUIRED)
- clinical research experience (preferred)
- experience working in an NCI Community Research Oncology Program (NCORP) (preferred)
 

*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. *

**Saint Alphonsus is not eligible to offer OPT STEM extensions.**

POSITION BENEFITS:

• Day 1 Benefits for colleagues! Our comprehensive benefit package includes medical, vision, dental, paid time off, 403B, education assistance and more.
• Daily Pay benefit available

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