Clinical Research Coordinator

Engage with us for your next career opportunity. Right Here.

Job Type:

Regular

Scheduled Hours:

40

Why Youll Love Working with St. Elizabeth Healthcare

At St. Elizabeth 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. Were 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 collaborating 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.

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. Collaborate with physicians to open new studies at St. Elizabeth 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 patients medical record as appropriate. Maintain the integrity and privacy of participants 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 patients progress and reports adverse events/protocol deviations as 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 unanticipated problems and study closure as mandated by the study sponsors St. Elizabeth Healthcare the Institutional Review Board (IRB).

Obtains patient biologic specimens or works with SEH laboratory/SEH clinical nursing staff to obtain laboratory specimens (blood urine saliva etc.). Maintains IATA certification for the safe handling and shipping of biologic specimens.

Works with clinical departments and finance department to ensure appropriate billing/coding of study related activity. Assists with development of research billing grids budgets and monitoring of reimbursements.

Performs other duties as assigned.

Education Credentials Licenses:

Associate degree in related field with 2 years related experience or Bachelors degree in related field

Specialized Knowledge:

Understanding of research processes

Ability to effectively manage and prioritize multiple tasks while meeting tight deadlines. Proficiency with Excel Word Outlook and PowerPoint is imperative.

Ability to work effectively and in a professional manner with physicians leadership SEH/SEP associates patients external business partners representatives of regulatory agencies and the general public.

Kind and Length of Experience:

Dependent upon educational background.

FLSA Status:

Exempt

Right Career. Right Here. If youre looking for the right careers in healthcare the right place to be is at St. Elizabeth. Join us and youll take pride in the level of care we offer our community.