Job Details

Senior Clinical Research Coordinator (SCRC)

Job Summary

The Senior Clinical Research Coordinator (SCRC) is responsible for managing and overseeing clinical trials and research projects. This role involves coordinating all aspects of clinical trials, including participant recruitment, data collection, regulatory compliance, and collaboration with sponsors and investigators. The SCRC also mentors junior staff, ensures quality standards, and supports research site operations.

Key Responsibilities

• Manage multiple clinical trials, including recruitment, scheduling, and adherence to study protocols.
• Perform study-related procedures, such as informed consent, specimen collection, and data reporting.
• Maintain and submit regulatory documents, including IRB submissions and adverse event reports.
• Collaborate with investigators, sponsors, and clinical teams to ensure successful trial execution.
• Train and mentor junior staff while contributing to quality assurance and process improvements.
• Support site feasibility assessments, sponsor meetings, audits, and monitor visits, addressing queries as needed.
• Oversee research billing, study drug accountability, and accurate documentation.

Qualifications

• Bachelor's degree in a science or health-related field required.
• 7+ years of clinical research experience, including drug or device trials.
• Certification in clinical research (CCRP or CCRC) required.
• Strong knowledge of FDA, OHRP, GCP, and other research regulations.
• Experience with lab processing, electronic data capture (EDC), and Clinical Trial Management Systems (CTMS).
• Phlebotomy certification and experience with ECGs preferred.
• Excellent organizational, problem-solving, and communication skills.

Skills and Abilities

• Ability to manage multiple studies simultaneously.
• Strong attention to detail, critical thinking, and ability to work independently.
• Proficient in Microsoft Office and data collection software.
• Comfortable mentoring others and improving research processes.

Additional Details

This is an exempt position that may require occasional travel and flexible hours based on study needs.