Job Description

Key Details:

• 100% onsite
• Candidate MUST be LOCAL, NO relocation
• Clinical skills preferred but not required

Clinical Research Coordinator – Key Responsibilities

As part of a collaborative clinical research team, the Clinical Research Coordinator plays a central role in the daily execution of assigned clinical trials. This position supports study activities in alignment with protocol requirements, internal procedures, and applicable regulatory standards (FDA, GCP, ICH).

Primary Responsibilities Include (but are not limited to):

• Assisting with participant screening and eligibility assessments for clinical trial enrollment
• Administering and documenting informed consent discussions with study participants
• Managing and conducting follow-up visits in accordance with study protocols
• Recording study activities and findings in source documentation and clinic records
• Entering data into electronic data capture (EDC) systems and responding to queries
• Collecting vital signs and performing ECGs as required by protocol
• Conducting routine lab procedures (e.g., blood collection, centrifugation, sample handling, packaging, and shipping)
• Managing medical record requests and tracking responses
• Maintaining study-related logs and organizing participant charts
• Monitoring and maintaining study supply inventory
• Scheduling patient visits and sending appointment reminders
• Preparing and updating source documents to ensure alignment with protocol requirements
• Supporting monitoring visits and resolving findings in a timely manner
• Ensuring timely review of reports and lab results by the study investigator
• Reporting serious adverse events (SAEs), protocol deviations, and other reportable items to sponsors and ethics committees as required
• Documenting adverse events and deviations accurately and promptly
• Reporting compliance concerns to the appropriate team members
• Maintaining clear and professional communication with internal teams and study partners
• Ensuring high-quality documentation practices following ALCOAC principles
• Assisting with recruitment and tracking of enrolled participants as needed
• Upholding patient and data confidentiality at all times
• Supporting general research site operations and assisting with other duties as assigned

Start-Up and Meeting Preparation:

• Completing required study-specific training and filing certificates as part of the study start-up process
• Participating in Site Initiation Visits (SIVs) and Investigator Meetings (IMs)
• Assisting with setup and maintenance of study-related technology or systems as needed

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