Clinical Research Coordinator: Lead Trials & Compliance

MaximaTek; Fremont (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

MaximaTek seeks a detail-oriented Clinical Research Coordinator (CRC) to manage daily trial operations, acting as the vital link between the clinical site, sponsors, and regulators to ensure integrity, patient safety, and adherence to ICH-GCP and FDA 21 CFR.

You will coordinate recruitment, screening, enrollment, and follow-up visits; maintain essential documents; manage data in EDC; monitor safety, and support audits to uphold GxP and cGMP standards while collaborating with CRAs during visits.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 0–5 years of clinical research or healthcare experience.
• Strong documentation and medical writing skills.
• Familiar with GxP and regulatory requirements.

Responsibilities

• Coordinate daily activities of clinical trials, including recruitment, screening, enrollment and follow-up visits.
• Maintain essential documents and ensure IRB/IEC alignment with SOPs.
• Enter data accurately into EDC and uphold ALCOA+ data integrity.
• Monitor participant safety and report adverse events to sponsors/regulators.
• Prepare and support audits to meet GxP/cGMP standards.
• Serve as liaison with CRAs during monitoring visits.

Skills

ICH-GCP

Human Subjects Protection

Regulatory compliance

Data entry

Medical writing

Education

Bachelor’s degree in Life Sciences / Nursing / Biomedical Sciences

Tools

EDC platforms

Clinical trial management software

21 CFR Part 11 familiarity

Job description

MaximaTek seeks a detail-oriented Clinical Research Coordinator (CRC) to manage daily trial operations, acting as the vital link between the clinical site, sponsors, and regulators to ensure integrity, patient safety, and adherence to ICH-GCP and FDA 21 CFR.

You will coordinate recruitment, screening, enrollment, and follow-up visits; maintain essential documents; manage data in EDC; monitor safety, and support audits to uphold GxP and cGMP standards while collaborating with CRAs during visits.