We are seeking a detail-oriented and organized Clinical Research Coordinator (CRC) to join our growing clinical research team. In this role, you will coordinate and oversee the day-to-day operations of clinical trials, ensuring studies are conducted in compliance with study protocols, Good Clinical Practice (GCP), sponsor requirements, and regulatory guidelines.
You will work closely with Principal Investigators, sponsors, Contract Research Organizations (CROs), and clinical staff to ensure the successful execution of research studies while maintaining the highest standards of participant safety and data integrity.
Key Responsibilities
Study Coordination
- Coordinate and execute clinical trial visits according to study protocols and timelines.
- Screen, recruit, consent, and enroll eligible study participants.
- Perform study-related procedures as delegated by the Principal Investigator.
- Collect, document, and maintain accurate source documentation and study data.
- Enter study data into electronic data capture (EDC) systems in a timely manner.
- Maintain study binders, regulatory files, and essential study documentation.
Regulatory & Compliance
- Ensure compliance with ICH-GCP, FDA regulations, IRB requirements, sponsor SOPs, and site policies.
- Prepare and submit IRB applications, amendments, continuing reviews, and reportable events.
- Maintain complete and audit-ready regulatory documentation throughout each study.
Sponsor & Monitor Support
- Serve as the primary point of contact for sponsors, CROs, and study monitors.
- Coordinate and support site initiation, monitoring, and close-out visits.
- Respond to monitoring findings and complete follow-up action items.
Participant Management
- Educate participants on study procedures and expectations.
- Schedule participant visits and coordinate follow-up appointments.
- Ensure participant confidentiality, safety, and protocol compliance throughout the study.
Qualifications
Required
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, or a related field (or equivalent clinical research experience).
- 1–2 years of clinical research experience preferred.
- Working knowledge of ICH-GCP guidelines and FDA regulations.
- Strong organizational and time management skills.
- Excellent written and verbal communication skills.
- High level of accuracy and attention to detail.
- Ability to manage multiple studies and deadlines simultaneously.
Preferred
- Experience using Electronic Data Capture (EDC) systems.
- Experience with eRegulatory platforms.
- Experience working in multi-site or high-volume clinical research settings.
- Phlebotomy, ECG, or other relevant clinical certifications.
If you are passionate about clinical research and committed to maintaining the highest standards of patient care and regulatory compliance, we encourage you to apply.
Pay: $28.00 - $33.00 per hour
Application Question(s):
- Do you have a Bachelor's degree in Life Sciences, Health Sciences, Nursing, or a related field?
- How many years of clinical research experience do you have?
- Are you familiar with ICH-GCP guidelines and FDA regulations?
- Do you have experience using Electronic Data Capture (EDC) systems? If yes, please specify
- Do you have experience using eRegulatory platforms? If yes, please specify
- Please leave the best phone number and email address to contact you throughout the interview process.
- Do you live in Sacramento or within a reasonable commute? Please be specific here.
Work Location: In person
