Clinical Research Coordinator I

About the Role

Seeking a motivated, detail-oriented Clinical Research Coordinator to assist investigators with basic to moderately complex clinical research studies. This role may involve managing multiple studies simultaneously, acting as a liaison with study sponsors, community, and participants. The coordinator will be responsible for managing and recording all phases of study protocols to ensure compliance.

Key Responsibilities

• Implements and manages all phases of clinical research studies and protocols.
• Ensures compliance with protocol guidelines and requirements of regulatory agencies and sponsoring organizations.
• Establishes and maintains appropriate record-keeping systems.
• Monitors participant progress and study activities.
• Analyzes, investigates, and reports adverse events.
• Makes decisions regarding notifying physicians of issues, stopping participant inclusion, or recommending protocol adjustments.
• Resolves protocol management issues and recommends corrective actions.
• Serves as liaison with investigators, clinical teams, funding/sponsoring agencies, and study participants and families.
• Recruits and enrolls study participants and facilitates participation in research and screening activities.
• Determines participant eligibility based on established study criteria and participant information.
• Develops and/or maintains study materials and informed consent documentation.
• Communicates with study participants and families regarding study purpose, procedures, screening opportunities, and visit requirements.
• Addresses routine participant and family questions and facilitates communication with appropriate clinical or research personnel.
• Ensures timely completion of all protocol and program requirements, including assessment, laboratory testing, procedures, visits, and follow-up activities.
• Coordinates study and/or screening activities, results, and follow-up requirements.
• Evaluates and interprets collected clinical data.
• Prepares oral or written presentations or reports summarizing study or program activities and progress.
• Collects, enters, maintains, and manages clinical and research data in accordance with approved protocols and established data-management procedures.
• Maintains study-specific databases and tracks participant, laboratory, screening, and follow-up information.
• Performs other duties as assigned.

Requirements & Tech Stack

• Basic Life Support (BLS) certification (from American Heart Association or American Red Cross; online certifications without a skills assessment component are not sufficient).
• Patient care setting experience.
• Ability to work typically sitting at a desk or table.
• Office equipment usage.

Qualifications

• Bachelor’s degree or a combination of education and/or experience may substitute for the minimum education requirement.
• Clinical Research skills.
• Clinical Study Protocols understanding.
• Communication skills.
• Computer Systems proficiency.
• Interpersonal Communication skills.
• Organizing skills.
• Research Support skills.