Clinical Research Coordinator in Orthopedics

Facility: OrthoIndy IHTSC Harcourt, Indianapolis, IN
Department: Orthopedic Research Foundation
Shift Details: Exempt, full-time, Monday-Friday, 8:00 am - 4:30 pm with availability to be flexible

At OrthoIndy everything we do is about creating a caring, connected and committed workforce that directly improves the quality of life for our employees and customers.

General Statement of Duties:
The Clinical Research Coordinator is responsible for the management of various clinical research activities for a variety of inpatient, outpatient, and animal studies. The Coordinator performs study specific clinical and regulatory activities across multiple study protocols in accordance with appropriate GCP/ICH regulations, SOPs and study specific protocols and processes.

Essential Duties:

1. Performs research duties according to FDA regulations/guidelines and GCP/HIPAA standards including; informed consent processes, contact of potential and enrolled subjects, data collection and entry into various EDC systems, assist with procedures, order tests, attend patient study visits, schedule patient appointments. Serves as primary liaison between investigators and sponsors.
2. Responsible for managing IRB submissions, continuing reviews, adverse events, serious adverse events and all correspondence between IRB, investigator and sponsor.
3. Assesses protocol feasibility. Negotiates and manages study contracts and budgets. Researches billing codes and costs. Invoices for all study procedures, facility reimbursement and patient stipends.
4. Hosts and prepares for external audits (sponsors, FDA, NIH, etc.)
5. Assists in writing papers and presentations for publication.
6. Responsible for maintaining registry for assigned investigators; including following FDA regulations and GCP standards, data collection, data entry, data analysis.
7. Performs literature searches and assist with learning labs.
8. Plans, organizes, and drafts minutes for meetings and teleconferences.
9. Completes project work as needed and as assigned by leadership and the Orthopaedic Research Foundation.

REQUIREMENTS/EXPERIENCE:

• Bachelor's Degree in related field required; Master's Degree preferred
• 1-2 years of research experience required; experienced coordinator with greater than 2 yearsexperience is preferred
• Membership/Certification through ACRP or SOCRA preferred

Equal Opportunity Employer