Job detail

Clinical Research Coordinator

Franciscan Alliance, Inc.

#Patient Care #Healthcare #GCP #Clinical Trials #CCRC #CCRP #IATA #Clinical Research Coordinator #IRB #Source Documentation

Quick overview

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.

Requirements summary

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 obtaining CCRP and CCRC certifications within 1.5 years.

associate degreebachelor degreePatient CareClinical ResearchSource DocumentationPatient RecruitmentInformed ConsentGood Clinical Practice (GCP)Research BillingAdverse Event MonitoringIRB OversightClinical Trial Implementation

Job description

Franciscan Health Lafayette East Campus 1701 S Creasy Ln Lafayette, Indiana 47905 The Clinical Research Coordinator II 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 12 ministries and access points across Indiana and Illinois, 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, Day shift, 40 hours/week.
An example could be 7am-3:30pm EST, however the hiring manager is flexible and open to a start time no later than 9am (ex.
9am-5:30pm) Collaborate with Research Financial Analyst to ensure research billing is accurate.
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.
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 TRAVEL IS REQUIRED: Never or Rarely EQUAL OPPORTUNITY EMPLOYER 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.

Clinical Research Coordinator

Quick overview

Requirements summary

Job description

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