Sr. Clinical Research Coordinator

Oversees day-to-day clinical trial activities

Oversees day-to-day clinical trial activities in accordance with Good Clinical Practice (GCP) guidelines. Independently manages or assists with clinical trials from startup through closeout. Coordinates protocol-related activities, including patient screening, recruitment, enrollment, and informed consent. Conducts feasibility assessments and study planning activities.

Coordinates and Manages Data and Specimens

• Manages clinical trial data and biological specimens.
• Prepares for sponsor monitoring visits and audits.
• Prepares and maintains regulatory and Institutional Review Board (IRB) documentation.

Training and Supervision

• Trains and supervises research staff on GCP and study-specific procedures.
• Affords clerical and technical support to ensure adherence to research protocols and data quality.

Workflow Management and Documentation

• Develops and revises workflows, training materials, SOPs, and guidance documents.
• Participates in departmental workgroups and process improvement initiatives.
• Prepares and submits materials to the IRB and other regulatory bodies in a timely manner.
• Maintains subject enrollment and tracking logs.
• Tracks study-related expenses and submits documentation for grant and study payments.
• Performs quality control reviews to ensure data integrity and regulatory compliance.
• Organizes and maintains study records and patient documentation.
• Designs and manages electronic data capture databases, when applicable.

Qualifications

• High School Diploma or equivalent with 6 years of clinical research experience, OR
• Bachelor's degree with 2 years of clinical research experience, OR
• Master's degree with 1 year of clinical research experience.