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Headlands Research · 1 day ago

Clinical Research Coordinator

Lake Worth, FL

Full-time

Onsite

Entry Level

1+ years exp

Headlands Research is a leading network of advanced clinical trial sites dedicated to enhancing clinical trial delivery within communities. They are seeking a Clinical Research Coordinator (CRC) to manage and execute Phase I-IV clinical studies in accordance with FDA regulations and GCP/ICH guidelines.

BiotechnologyHealth CareMedical

Responsibilities

Coordinate all aspects of assigned clinical trials from site initiation to study close-out

Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards

Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs

Manage subject recruitment, informed consent, and retention strategies

Ensure timely data entry and resolution of EDC queries

Report and follow up on all adverse events, serious adverse events, and deviations

Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders

Prepare for and participate in monitoring visits, audits, and inspections

Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems

Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained)

Attend investigator meetings and provide cross-functional support as needed

Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control

Qualification

FDA regulationsICH-GCP regulationsClinical trial proceduresMedical terminologyClinical documentationMicrosoft OfficeInterpersonal skillsCommunication skillsOrganizational skillsDetail-oriented

Required

High school diploma or GED

Minimum of 1 year of experience as a Clinical Research Coordinator OR Minimum of 2 years of college within a health-related program OR Licensed as a Licensed Practical Nurse (LPN) or higher OR Bachelor's degree in a health or scientific-related program

Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures

Proficiency in medical terminology and clinical documentation practices

Strong interpersonal, verbal, and written communication skills

Organized, detail-oriented, and capable of managing multiple priorities

Proficient in Microsoft Office and other clinical research systems