Clinical Research Coordinator

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

About the Role: Clinical Research Coordinator (CRC)

We are seeking a detail-oriented Clinical Research Coordinator (CRC) to manage and oversee the daily operations of clinical trials. In this role, you will act as the vital link between the clinical site, the study sponsors, and the regulatory bodies, ensuring that all research is conducted with the highest integrity, patient safety, and adherence to strict regulatory standards (such as ICH-GCP and FDA 21 CFR).

Core Responsibilities

• Study Management: Coordinate the daily activities of clinical trials, including patient recruitment, screening, enrollment, and follow-up visits.
• Regulatory Compliance: Maintain comprehensive Essential Document files and ensure all study activities align with IRB/IEC requirements and SOPs.
• Data Integrity: Perform accurate data entry into Electronic Data Capture (EDC) systems and ensure the "ALCOA+" principles of data integrity are upheld.
• Patient Safety: Monitor participant well-being, report Adverse Events (AEs) and Serious Adverse Events (SAEs) promptly to sponsors and regulatory boards.
• Quality Assurance: Author and maintain source documentation and assist in internal and external audits to ensure GxP and cGMP requirements are met.
• Site Liaison: Serve as the primary point of contact for Clinical Research Associates (CRAs) during monitoring visits.

Qualifications

• Education: Bachelor’s degree in Life Sciences, Nursing, Biomedical Sciences, or a related healthcare field (Required).
• Experience: 0–5 years of experience in clinical research, healthcare administration, or academic laboratory environments.
• Technical Skills (Required):
• Strong understanding of ICH-GCP guidelines and Human Subjects Protection.
• Proficiency in clinical trial management software and EDC platforms.
• Familiarity with 21 CFR Part 11 regarding electronic records and signatures.
• Excellent medical writing and documentation skills.
• Preferred Skills:
• Certification (or eligibility) for CCRC (ACRP) or CCRP (SoCRA).
• Experience with medical device clinical trials (ISO 14155).
• Knowledge of Phlebotomy or basic clinical assessment skills.

What We Offer

• Targeted Placement: Direct marketing to our network of hiring managers in the Life Sciences and MedTech industries.
• Technical Resume Rebuild: Optimization of your profile to highlight clinical expertise alongside regulatory documentation skills.
• Interview Coaching: Guidance on behavioral interviews and regulatory compliance case studies.