Orthopedic Clinical Research Coordinator | IRB/Data

OrthoIndy; Indianapolis (IN); On-site; USD 52,000 - 78,000; Full time

Job summary

OrthoIndy IHTSC Harcourt in Indianapolis, IN is seeking a Clinical Research Coordinator for full-time, 8:00 am - 4:30 pm with flexibility. The role supports inpatient, outpatient, and animal studies, ensuring GCP/ICH, SOPs and study protocols are followed.

The coordinator liaises with investigators and sponsors, handles IRB processes, budgeting, and audits. Qualifications include a Bachelor's degree in a related field and 1–2 years of research experience; ACRP or SOCRA certification is

Qualifications

• Bachelor's Degree in related field required; Master's Degree preferred.

Responsibilities

• Performs study-specific clinical and regulatory activities across multiple study protocols in accordance with GCP/ICH regulations, SOPs and study protocols.
• Manages IRB submissions, continuing reviews, adverse events and communications between IRB, investigator and sponsor.
• Researches billing codes and costs; invoices for all study procedures, facility reimbursement and patient stipends.
• Hosts and prepares for external audits (sponsors, FDA, NIH, etc.).
• Assists in writing papers and presentations for publication.
• Maintains registry for assigned investigators; follows FDA regulations and GCP standards, data collection and analysis.
• Performs literature searches and assists with learning labs.
• Plans, organizes, and drafts minutes for meetings and teleconferences.

Education

Bachelor's Degree in related field

Master's Degree preferred

Job description

OrthoIndy IHTSC Harcourt in Indianapolis, IN is seeking a Clinical Research Coordinator for full-time, 8:00 am - 4:30 pm with flexibility. The role supports inpatient, outpatient, and animal studies, ensuring GCP/ICH, SOPs and study protocols are followed.

The coordinator liaises with investigators and sponsors, handles IRB processes, budgeting, and audits. Qualifications include a Bachelor's degree in a related field and 1–2 years of research experience; ACRP or SOCRA certification is