Phase 1 Clinical Research Coordinator I

Key Responsibilities

• Conduct study-required procedures within study-specific guidelines and timelines, documenting in real-time (electronic or paper).
• Perform all study-related procedures after training and delegation, including:
• ECGs, vital signs
• Administering subject home medication
• Administering Investigational Product (IP)/study drug under pharmacy staff direction
• Administering questionnaires as required per protocol
• Starting IVs
• Drawing and processing blood per lab manual
• Urine collection
• Keeping intake and output sheets
• Collecting and processing bodily secretions per study guidelines
• Subject education and training.
• Answer phone calls and direct appropriately.
• Order subject meals and ensure they eat per protocol requirements.
• Notify investigator or delegated staff of any changes in subject status or complaints.
• Administer over-the-counter medication under investigator direction.
• Assist subjects with hygiene needs; keep rooms clean and change bed linen.
• Escort subjects on walks and attend during smoking breaks.
• Maintain stock of snacks, sodas, and water; order or provide lists of needed supplies.
• Keep drawers and closets stocked with needed supplies.
• Monitor visitors and clinic visitation hours.
• Document all adverse events per protocol; notify investigator/coordinator of potential adverse reactions.
• Check new subject bags for prohibited items upon check-in; confiscate and secure prohibited items.
• Perform all duties according to established policies, procedures, regulatory requirements, and professional standards.
• File documents (e.g., subject source, labs).
• Enter clinical research data into appropriate fields.
• Transfer data from paper formats or electric data via computer, recorders, or scanners.
• Review and edit data for completeness and accuracy; follow up with subjects to resolve data issues.
• Assist with research trial audits.
• Prepare documents and charts for subject visits.
• Prepare correspondence, documentation, or presentation materials on findings.

Requirements & Tech Stack

• Knowledge of commonly used concepts, practices, and procedures in the Research field.
• Strong attention to detail.
• Excellent communication skills.

Qualifications

• High School Diploma or GED required.
• BLS and ACLS training required.
• Bachelor’s degree preferred.
• Medical Assistant certification or diploma from an accredited program preferred.
• Professional certification in phlebotomy from a recognized program preferred.
• Valid documentation and authorization to work in the U.S.

Work Environment & Physical Demands

• Clinic / office setting.
• Able to lift at least 30 lbs.
• Able to sit for long periods (at least 50%).
• Able to type and do computer work for long periods.

Compensation

• $25 to $30 per hour, depending on experience.