Clinical Trials Research Coordinator

Description

Summary

The Clinical Trials Research Coordinator (CTRC) is responsible for the planning, execution, and oversight of clinical trials from initiation through to completion, ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards. The CTRC works closely with cross-functional teams including IBJI leadership, investigators, other research coordinators, data managers, and regulatory affairs to ensure the successful delivery of study objectives. Oversees the collection of data and entry, performs data analysis

for studies including retrospective trials, and outcomes trials. The CTRC will be an integral member of the research team in compliance with all regulatory, institutional, and departmental requirements. The candidate will participate in all research study related activities and quality assurance of data for assigned research projects.

Job Duties and Responsibilities

• Oversee and manage day-to-day operations of clinical trials, including site selection, initiation, monitoring, and close-out.
•  Develop and maintain study protocols, informed consent forms, and other essential documents.
• Coordinate with internal teams and external vendors/CROs to ensure timelines and quality objectives are met.
• Monitor trial progress and budgets, ensuring compliance with regulatory and ethical guidelines.
• Manage clinical trial timelines and proactively identify risks or issues.
• Prepare for and participate in audits and regulatory inspections.
• May train and oversee other trial staff.
• Collaborate with medical monitors, data management, biostatistics, and regulatory affairs throughout the study lifecycle.
• Ensure accurate and timely reporting of adverse events and serious adverse events.
• Maintain Trial Master File (TMF) and ensure documentation is complete and audit- ready.
• Conducts the informed consent process for all prospective trials (as needed).
• Manages data collection specific to research studies including, but not limited to, the performance of observational measurements, collection of clinical data from patients directly, and manages data amongst studies with a multidisciplinary team.
• Responsible for efforts to meet patient enrollment targets related to research projects and develops and implements recruiting strategies to meet enrollment targets.
• Under supervision from a Principal Investigator, manages and executes IRB submissions for initial approvals, continuing reviews, amendments. Ensures timeliness and accuracy of submissions and no lapses in approvals for study.
• Collaborates with the research team and research administration, as needed. To ensure that research subjects are treated in accordance with all mandated requirements. Ensures that standards regarding the subject registration, protocol specific tests, and required documentation are adhered to. Reports deviation as appropriate and resolves issues when possible. Escalates issues to leadership as needed. 
• Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of research data management.
• A qualified candidate has the ability to work independently, communicate in an effective manner with management, clinical staff, external sponsors, and patients at IBJI.

Requirements

Minimum Requirements

• Bachelor’s Degree in related concentration
• Scientific Background
• Proficient use of computers and software; Including Microsoft Office Suite
• Experience conducting Statistical Analysis- Clinical Data Analysis and Management 
• Understanding of Good Clinical Practices and regulatory requirements

Base salary offers for this position may vary based on factors such as location, skills and relevant experience. We offer the following benefits to those who are benefit eligible (30+ hours a week):  medical, dental, vision, life and AD&D insurance, long and short term disability, 401k program with company match and profit sharing, wellness program, health savings accounts, flexible savings accounts, ID protection plan and accident, critical illness and hospital benefits. In addition, we offer paid holidays and paid time off.