Senior Clinical Research Coordinator - 248229

The Senior Clinical Research Coordinator (Senior CRC) is responsible for the oversight, coordination, and execution of clinical trials at the site level. This role partners closely with the Regional Site Director to ensure compliance, efficiency, and high-quality performance across all clinical research activities. The Senior CRC also serves as a key resource to site staff, providing guidance, training, and operational support.

Key Responsibilities

• Collaborate with the Regional Site Director to support daily site operations, ensuring adherence to study protocols, regulatory requirements, and internal standard operating procedures (SOPs).
• Lead, train, and mentor Clinical Research Coordinators (CRCs) and site staff, promoting a compliant and efficient research environment.
• Review, interpret, and communicate study protocols, amendments, and updates to the research team.
• Coordinate and oversee key study visits, including Site Initiation Visits (SIV), Pre-Study Validation Visits (PSV), and Interim Monitoring Visits (IMV).
• Support and assist CRC team members as needed to meet study goals and operational demands.
• Conduct and manage clinical trials in accordance with protocol guidelines, Good Clinical Practice (GCP), and organizational policies.
• Ensure timely, accurate data entry into sponsor systems and proactively resolve data queries.
• Serve as a primary point of contact for sponsors, Contract Research Organizations (CROs), Clinical Research Associates (CRAs), and Institutional Review Boards (IRBs).
• Perform administrative responsibilities, including ordering study supplies and equipment and maintaining site readiness.
• Manage study start-up activities, including regulatory documentation, staff training, and adherence to study timelines for assigned protocols.

Qualifications

• Associate’s degree and/or completion of an accredited healthcare certification program required.
• Minimum of 3 years of experience in clinical research required.
• At least 3 years of experience as a Clinical Research Coordinator (CRC) preferred.
• Demonstrated ability and willingness to step into a leadership role.
• Comprehensive knowledge of FDA regulations, Good Clinical Practice (GCP), and patient confidentiality standards.
• Strong attention to detail with excellent organizational skills.
• Excellent written and verbal communication skills.
• Proven ability to manage multiple priorities and adapt in a fast-paced, dynamic environment.