Coordinador de Investigación Clínica CRC II

NATIONAL CLINICAL TRIALS INC; Los Angeles (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k)

Paid time off

Job summary

National Clinical Trials Inc. in Los Angeles, CA seeks a motivated Clinical Research Coordinator II to coordinate and manage active clinical trials, ensuring protocol adherence and data integrity.

You will interact with sponsors, CROs, and IRBs while maintaining strict compliance with FDA regulations and GCP/ICH guidelines. The role requires a Bachelor's degree in life sciences or related field and 2+ years of CRC experience, with proficiency in EDC systems (REDCap, Medidata Rave) and CTMS.

Qualifications

• Bachelor's degree in life sciences, healthcare, or a related field is required.
• Minimum 2+ years of experience as a Clinical Research Coordinator (CRC).
• Solid knowledge of GCP, ICH guidelines, FDA regulations, and HIPAA compliance.
• Experience with EDC systems (REDCap, Medidata Rave) and CTMS platforms.
• ACRP (CCRC) or SOCRA (CCRP) certification preferred.
• Strong organizational skills with exceptional attention to detail and accuracy.
• Excellent interpersonal and communication skills for working with patients and research teams.
• Ability to manage multiple protocols simultaneously in a fast-paced research environment.

Responsibilities

• Coordinate and manage day-to-day operations of clinical trials in compliance with FDA regulations, GCP, and ICH guidelines.
• Screen, enroll, and follow up with study participants while ensuring protocol adherence.
• Collect, record, and maintain accurate study data in EDC systems and source documents.
• Serve as a primary point of contact for sponsors, CROs, and IRB communications.
• Prepare and submit regulatory documents, including IRB submissions, amendments, and continuing reviews.
• Monitor patient safety and report adverse events (AEs) and serious adverse events (SAEs) per protocol requirements.
• Collaborate with principal investigators, sub-investigators, and multidisciplinary clinical teams.
• Support site initiation visits, monitoring visits, and audits conducted by sponsors or regulatory agencies.

Skills

Attention to detail

Communication

Multitasking

Team collaboration

Education

Bachelor's degree in life sciences or related field

Tools

REDCap

Medidata Rave

CTMS

Job description

Benefits:

• 401(k)
• Paid time off

About the Role:

National Clinical Trials Inc. is looking for a motivated and detail-oriented Clinical Research Coordinator II (CRC II) to join our dynamic team in Los Angeles, CA. In this role, you\'ll play a critical part in advancing medical research by coordinating and managing clinical trials that make a real difference in patients\' lives. If you\'re passionate about science, patient care, and research excellence, we want to hear from you!

Responsibilities:

• Coordinate and manage day-to-day operations of clinical trials in compliance with FDA regulations, GCP, and ICH guidelines
• Screen, enroll, and follow up with study participants while ensuring protocol adherence
• Collect, record, and maintain accurate study data in EDC systems and source documents
• Serve as a primary point of contact for sponsors, CROs, and IRB communications
• Prepare and submit regulatory documents, including IRB submissions, amendments, and continuing reviews
• Monitor patient safety and report adverse events (AEs) and serious adverse events (SAEs) per protocol requirements
• Collaborate with principal investigators, sub-investigators, and multidisciplinary clinical teams
• Support site initiation visits, monitoring visits, and audits conducted by sponsors or regulatory agencies

Requirements:

• Bachelor\'s degree in life sciences, healthcare, or a related field required
• Minimum 2+ years of experience as a Clinical Research Coordinator (CRC)
• Solid knowledge of GCP, ICH guidelines, FDA regulations, and HIPAA compliance
• Experience with EDC systems (e.g., REDCap, Medidata Rave) and CTMS platforms
• ACRP (CCRC) or SOCRA (CCRP) certification preferred
• Strong organizational skills with exceptional attention to detail and accuracy
• Excellent interpersonal and communication skills for working with patients and research teams
• Ability to manage multiple protocols simultaneously in a fast-paced research environment

About Us:

National Clinical Trials Inc. is a leading clinical research organization based in Los Angeles, CA, dedicated to advancing healthcare through innovative and rigorous clinical studies. Our patients trust us for our commitment to safety, integrity, and excellence in every trial we conduct. Our team members thrive in a collaborative, mission-driven environment where their work directly contributes to groundbreaking medical discoveries.