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Headlands Research · 16 hours ago

Clinical Research Coordinator

Portland, OR

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. The Clinical Research Coordinator will coordinate all aspects of assigned clinical trials, ensuring compliance with protocols and regulations while managing subject recruitment and data entry.

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

Clinical trial coordinationFDA regulationsICH-GCP guidelinesElectronic data capture (EDC)Medical terminologyClinical documentationMicrosoft OfficeInterpersonal skillsVerbal communicationWritten communicationOrganizational skillsDetail-oriented