Research Coordinator

Research Coordinator page is loaded## Research Coordinator locations:
Edgewood, Kentucky time type:
Full time posted on:
Posted Todayjob requisition :
JR309321
** Engage with us for your next career opportunity. Right Here.
**** Job Type:
** Regular
* * Scheduled

Hours:

** 40
* * Why You’ll Love Working with St. Elizabeth Healthcare
** zabeth Healthcare, every role supports our mission to provide comprehensive and compassionate care to the communities we serve. For more than 160 years, St. Elizabeth Healthcare has been a trusted provider of quality care across Kentucky, Indiana, and Ohio. We’re guided by our mission to improve the health of the communities we serve and by our values of excellence, integrity, compassion, and teamwork.

Our associates are the heart of everything we do.
** Benefits That Support You
** We invest in you — personally and professionally.

Enjoy:

- Competitive pay and comprehensive health coverage within the first 30 days.

- Generous paid time off and flexible work schedules
- Retirement savings with employer match
- Tuition reimbursement and professional development opportunities
- Wellness, mental health, and recognition programs
- Career advancement through mentorship and internal mobility
*
* Job Summary:

** Coordinate clinical research studies for the principal investigators and coordinates and promotes research program within St. Elizabeth and the community. Responsible for networking with physicians to open studies, educating staff about current studies, educating clients about studies and obtaining informed consents. Responsibilities include screening and enrolling subjects in studies and managing their participation according to ethical, regulatory, and protocol specific requirements.

Responsibilities also include data collection and submission as well as Regulatory compliance.
Demonstrate respect, dignity, kindness and empathy in each encounter with all patients, families, visitors and other employees regardless of cultural background.
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* Job Description:

*** Coordinate clinical research studies conducted by the principal investigator.  Has a thorough understanding of the protocols.  Educate and provide in-service to associates in the Medical Center that will be affected by the study.  Network with physicians to open new studies zabeth and to promote the research program within the community. Work directly with principal investigator to design appropriate recruitment strategies, communication plan, and patient safety monitoring plan.
* Conducts research studies according to Office for Human Research Protections (OHRP) and US Food and Drug Administration (FDA) regulations and guidelines.  Follows Good Clinical Practices, Good Laboratory Practices, St. Elizabeth Healthcare policies, and maintains related certifications.
* Confer with potential study participants to explain the study and obtain the study specific, IRB approved informed consent, as well as appropriate HIPAA Authorization before performing any study related procedures.  Review with the participant and family all study requirements including diagnostic procedures, questionnaires, and treatments.
* Conduct participant research visits and collect/record research related data.  Submit data to study sponsors as required and documents in the patient’s medical record as appropriate.  Maintain the integrity and privacy of participant’s research protocol chart with all required source data.
* Initiate/coordinate drug orders, laboratory/imaging procedures and treatments for participants based on protocol requirements. Maintain investigational device/product inventory or coordinate investigational device/product accountability with St. Elizabeth pharmacy or appropriate clinical department.
* Ensure compliance with protocol guidelines and requirements of regulatory agencies, including required documentation and record retention.
* Monitor patient’s progress and reports adverse events/protocol deviations as required.  Participating in quality assurance activities of the sponsor, the FDA, IRB, other regulatory and accrediting agencies.
* Assist with documentation and submission for approvals, revisions, renewals, informed consents,…