Job Description

Job Description

Position Overview

We are seeking a motivated and detail-oriented  Clinical Research Coordinator (CRC)to join our orthopedic surgery practice. The CRC will play a key role in coordinating and managing clinical research studies, with a focus on shoulder and elbow disorders and outcome-based clinical research. The ideal candidate has prior experience with  FDA-regulated clinical trials (IDE or IND) and is passionate about advancing musculoskeletal research while ensuring regulatory compliance and patient safety.

Key Responsibilities

• Coordinate and manage all aspects of clinical research studies, including subject recruitment, informed consent, scheduling, and follow-up.
• Serve as primary liaison among investigators, study sponsors, monitors, and regulatory agencies.
• Ensure compliance with study protocols, FDA regulations, Good Clinical Practice (GCP) guidelines, and institutional policies.
• Collect, process, and maintain accurate study documentation and regulatory submissions (IRB, FDA, sponsor correspondence).
• Prepare and manage case report forms, source documents, and electronic data entry.
• Monitor study progress, track timelines, and ensure high-quality data integrity.
• Assist in protocol development, budget preparation, and study feasibility assessments.
• Assist in management of ongoing studies, including clinical outcomes database repository

Qualifications

• Bachelor’s degree in life sciences, nursing, or related field (Master’s or RN preferred).
• Minimum 2+ years of clinical research experience ; orthopedic or surgical research experience preferred.
• Strong knowledge of  FDA clinical trial regulations, GCP, and IRB processes .
• Certified Clinical Research Coordinator (CCRC) or willingness to obtain certification preferred.
• Excellent organizational, communication, and problem-solving skills.
• Ability to work independently, manage multiple projects, and maintain attention to detail.
• Comfortable interacting with patients, physicians, and multidisciplinary teams.

Why Join Us?

• Work closely with internationally nationally recognized orthopedic surgeons specializing in complex shoulder and elbow conditions.
• Participate in cutting-edge clinical trials that shape the future of surgical innovation and patient care.
• Collaborative, supportive, and research-driven practice environment.
• Competitive salary and benefits package.

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