Clinical Research Coordinator CRC II

NATIONAL CLINICAL TRIALS INC; Los Angeles (CA); Vor Ort; USD 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

401(k)

Paid time off

Zusammenfassung

National Clinical Trials Inc. is seeking a detail-oriented Clinical Research Coordinator II (CRC II) to join our team in Los Angeles, CA. You will coordinate and manage clinical trials, ensuring FDA/GCP/ICH compliance, and serve as the main liaison with sponsors and IRB.

Requirements include a Bachelor's degree in a life sciences field, 2+ years CRC experience, and knowledge of GCP/ICH/FDA/HIPAA. EDC tools such as REDCap and Medidata Rave are preferred, with CTMS experience.

Qualifikationen

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

Aufgaben

• Coordinate and manage day-to-day operations of clinical trials.
• Screen, enroll, and follow up with study participants.
• Collect, record, and maintain data in EDC systems and source documents.
• Serve as primary contact for sponsors, CROs, and IRB communications.
• Prepare and submit regulatory documents, including IRB submissions.
• Monitor patient safety and report AEs and SAEs per protocol requirements.
• Collaborate with principal investigators, sub-investigators, and multidisciplinary clinical teams.
• Support site initiation visits, monitoring visits, and audits.

Kenntnisse

Organizational skills

Attention to detail

Communication skills

Multitasking

Ausbildung

Bachelor's degree in life sciences/healthcare

Tools

REDCap

Medidata Rave

CTMS

Jobbeschreibung

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.