Clinical Research Coordinator

OrthoIndy; Indianapolis (IN); Presencial; USD 52 000 - 78 000; Tempo integral

Resumo da oferta

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

Qualificações

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

Responsabilidades

• 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.

Formação académica

Bachelor's Degree in related field

Master's Degree preferred

Descrição da oferta de emprego

full-time, Monday-Friday, 8:00 am - 4:30 pm with availability to be flexible

Job Description

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.

• 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.
• Responsible for managing IRB submissions, continuing reviews, adverse events, serious adverse events and all correspondence between IRB, investigator and sponsor.
• 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.
• Hosts and prepares for external audits (sponsors, FDA, NIH, etc.)
• Assists in writing papers and presentations for publication.
• Responsible for maintaining registry for assigned investigators; including following FDA regulations and GCP standards, data collection, data entry, data analysis.
• Performs literature searches and assist with learning labs.
• Plans, organizes, and drafts minutes for meetings and teleconferences.
• 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 years experience is preferred
• Membership/Certification through ACRP or SOCRA preferred

Equal Opportunity Employer

Location

Indianapolis , Indiana , United States

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