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The coordinator implements and completes clinical research protocols, including obtaining informed consent and performing protocol-specified procedures. They are responsible for recruiting subjects, maintaining documentation, and reporting adverse events to sponsors.
An associate degree is required, with a bachelor's degree preferred, along with 3 years of research or nursing experience. Mandatory certifications include IATA training and both CCRP and CCRC certifications within specified timeframes.
The Clinical Research Coordinator provides services related to the implementation and completion of clinical research protocols. This includes tasks such as obtaining informed consent for clinical trial participation, training other research team members, and completing all protocol-specified procedures.
WHO WE ARE
Franciscan Health is a leading healthcare organization dedicated to providing exceptional patient care and promoting health and wellness in our community. Our mission is to ensure that every patient receives the highest quality of care through innovation, compassion, and excellence. With 11 ministries and access points across Indiana, Franciscan Health is one of the largest Catholic health care systems in the Midwest. Franciscan Health takes pride in hiring coworkers who provide compassionate, comprehensive care for our patients and the communities we serve.
WHAT YOU CAN EXPECT
Schedule: Monday – Friday, 8am - 5pm (There is some flexibility with start/end time if needed)
Collaborate with Research Financial Analyst to ensure research billing is accurate.
Conduct a thorough and ongoing informed consent process and document appropriately.
Conduct clinical trials that involve human subjects according to written protocols and departmental standards while adhering to Good Clinical Practice (GCP) Guidelines.
Create and complete valid source documentation per GCP requirements.
Document and maintain all research activities including patient visits.
Identify key elements of subject safety including, IRB oversight, study documentation, and event reporting.
Identify and explain key protocol elements to study subjects and perform study tasks as dictated by protocol.
Maintain research certification on a biannual or triannual basis, as appropriate.
Monitor adverse events and report serious events to the research sponsor according to written protocols and departmental standards.
Recruit and screen potential subjects for inclusion in clinical trials according to written protocols.
Respond to data queries issued by the study sponsor or sponsor's representative in a timely manner.
QUALIFICATIONS
Associate degree required (Health Administration, Business, Health Science, Nursing/Patient Care preferred)
Bachelor's Degree preferred
3 years research experience required
IF RN, 3 years Nursing/Patient Care required
IATA training within 6 months of hire date required
Certified Clinical Research Professional (CCRP) within 1.5 years required
Certified Clinical Research Coordinator (CCRC) within 1.5 years required
It is the policy of Franciscan Alliance to provide equal employment to its employees and qualified applicants for employment as otherwise required by an applicable local, state or Federal law.
Franciscan Alliance reserves a Right of Conscience objection in the event local, state or Federal ordinances that violate its values and the free exercise of its religious rights.
Franciscan Alliance is committed to equal employment opportunity.
Franciscan provides eligible employees with comprehensive benefit offerings. Find an overview on the benefit section of our career site, jobs.franciscanhealth.org.
A trusted leader in providing faith-based, integrated health care, Franciscan Alliance brings together the latest technology, innovative procedures and the brightest, most compassionate people to serve our patients in Indiana, Illinois and Michigan. Throughout our 13 hospitals and many medical practices, we offer a number of nationally recognized Centers of Health Care Excellence. Our health care system carries forth Christ’s healing ministry and strengthens the Catholic health care mission by: Providing a broad, coordinated continuum of health care services with an emphasis on improving the health of persons and communities; Treating the mind, body and spirit with holistic and comprehensive medical options; Developing creative structures for health care delivery; Being advocates for those in need; Identifying and developing our sisters and laity for Franciscan leadership.
