- Location
- IN - Indianapolis, United States of America
- Type
- Full-time
- Department
- Healthcare
- Education
- Bachelor
- Source
- Workday
Description
The Clinical Research Coordinator II independently coordinates and manages clinical research studies involving human participants in accordance with study protocols, Good Clinical Practice (GCP) guidelines, regulatory requirements, and organizational policies. This role is responsible for participant recruitment and enrollment, informed consent, study visit coordination, data and documentation management, regulatory compliance, subject safety monitoring, and collaboration with investigators, sponsors, and research team members. The Clinical Research Coordinator II may provide guidance and training to less experienced research staff and serves as a key resource in ensuring the successful execution of clinical trials.
WHO WE ARE
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 that 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)
Independently coordinate and conduct clinical research studies according to approved protocols, GCP guidelines, sponsor requirements, and departmental standards. Schedule and manage study visits, perform protocol-required activities, and ensure study milestones are achieved.
Identify, recruit, screen, and enroll eligible participants. Conduct and document informed consent discussions, ensuring participants understand study requirements, risks, and benefits throughout study participation.
Create, maintain, and complete source documentation, case report forms, and study records. Ensure accuracy, completeness, and timeliness of research data and documentation.
Maintain regulatory files and required certifications. Prepare and submit study-related documentation to Institutional Review Boards (IRBs), sponsors, and other regulatory entities. Respond to monitoring visits, audits, and data queries.
Monitor participant safety throughout the study, identify and document adverse events, and ensure timely reporting to sponsors, investigators, and regulatory bodies in accordance with protocol and regulatory requirements.
Collaborate with research finance personnel to support accurate research billing and study budget compliance. Provide training, mentorship, and operational support to research staff as needed.
QUALIFICATIONS
Associate degree required (Health Administration, Business, Health Science, Nursing/Patient Care preferred)
Bachelor's Degree preferred
2 years of research OR 2 years of clinical experience required
IATA training within 6 months of hire date required
Certified Clinical Research Professional (CCRP) OR Certified Clinical Research Coordinator (CCRC) within 1.5 years required
TRAVEL IS REQUIRED:
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.
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.
