Open Rank Clinical Research Coordinator (Entry – Intermediate)

Key Responsibilities

• Trial Operations & Management: Assist with and oversee day-to-day operations for multiple clinical trials, acting as the Primary Coordinator to ensure all study activities align with the established protocol.
• Subject Recruitment & Screening: Participate and lead recruitment efforts by interviewing prospective subjects, reviewing medical histories against inclusion/exclusion criteria, and confirming final eligibility.
• Informed Consent Oversight: Execute and document the informed consent process, ensuring all participants are fully educated on study details and that legal documentation is filed per regulatory standards.
• Protocol Execution: Perform study-related procedures, assessments, and drug administrations as defined in the research protocol and in compliance with governing bodies.
• Subject Scheduling & Coordination: Manage the logistics of subject participation, including the coordination of clinic space and multidisciplinary support (Radiology, Pharmacy, Lab, and PIs).
• Clinical Assessments: Perform technical clinical tasks including phlebotomy (venipuncture), specimen processing/shipping, EKGs, and monitoring vital signs.
• Data Management: Abstract, code, and record patient data into Case Report Forms (CRFs) and clinical trial databases with a focus on accuracy and timely entry.
• Regulatory Compliance: Maintain meticulous study records to ensure strict adherence to FDA guidelines, Good Clinical Practice (GCP), and hospital Standard Operating Procedures (SOPs).
• Safety Reporting: Promptly alert Principal Investigators, sponsors, and the FDA regarding Serious Adverse Events (SAEs) to ensure patient safety and data integrity.
• Leadership & Quality Improvement: Assist in the creation of new clinical processes and quality initiatives while training junior staff members on study protocols.

Qualifications

• Entry Level: Bachelor’s degree in science or health related field. One (1) year clinical research or related experience.
• Intermediate Level: Bachelor’s degree in science or health related field. Two (2) years clinical research or related experience.