Senior Clinical Research Coordinator 251809

We are looking to add a Senior Clinical Research Coordinator to a growing team with lots of room for growth. This is a full time, permanent onsite position that comes with full benefits, PTO etc. Relocation or Sponsorship will not be offered at this time.

Position Summary

The Senior Clinical Research Coordinator (SCRC) is responsible for the planning,

coordination, and execution of clinical research studies in compliance with regulatory

requirements, institutional policies, and study protocols. This role provides advanced

coordination of multiple clinical trials, ensures high-quality data collection, supports regulatory

submissions, and may mentor junior research staff.

Key Responsibilities

• Coordinate and manage all aspects of assigned clinical trials from start-up through closeout.
• Ensure study conduct follows protocol, Good Clinical Practice (GCP), and regulatory guidelines.
• Schedule and oversee study visits, procedures, and participant follow-up.
• Maintain study timelines, enrollment targets, and protocol compliance.
• Prepare and submit regulatory documents to Institutional Review Boards (IRB), sponsors, and regulatory agencies.
• Maintain regulatory binders and essential study documentation.
• Ensure adherence to FDA, ICH-GCP, and institutional requirements.
• Screen, recruit, and consent study participants.
• Educate participants about study procedures, risks, and benefits.
• Monitor participant safety and report adverse events according to protocol.
• Collect, review, and enter clinical trial data into electronic data capture systems (EDC).
• Resolve data queries and ensure accuracy and completeness of study records.
• Maintain source documentation and case report forms (CRFs).
• Serve as primary contact for sponsor and CRO monitors.
• Prepare for site visits, monitoring visits, and audits.
• Address findings and implement corrective actions when needed.
• Provide training and guidance to junior clinical research coordinators and support staff.
• Assist with study feasibility assessments and site start-up activities.
• Contribute to process improvements and research program development.

Education

• Bachelor’s degree in Life Sciences, Nursing, Public Health, or related field required
• Master’s degree preferred

Experience

• 4–7 years of clinical research coordination experience
• Experience managing multiple clinical trials preferred
• Experience with regulatory submissions and monitoring visits

Certifications (Preferred)

• CCRC (Certified Clinical Research Coordinator) – ACRP
• CCRP (Certified Clinical Research Professional) – SoCRA

Skills & Competencies

• Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes
• Excellent organizational and project management skills
• Strong attention to detail and documentation practices
• Ability to manage multiple studies simultaneously
• Effective communication and interpersonal skills
• Proficiency in EDC systems, CTMS, and Microsoft Office