Lead Clinical Research Coordinator/Manager

Lead Clinical Research Coordinator/Manager

Location:
Canoga Park, CA

Schedule:
Monday–Friday, 9:00 AM–5:00 PM (On-site)

Pay:
$38 - $45/hour

Overview:

We are seeking a
Lead Clinical Research Coordinator (CRC)
who is ready to take ownership of a new clinical research program and grow into a management role. This position offers the opportunity to be the backbone of a developing research department—balancing hands-on clinical trial execution with leadership and process-building responsibilities.

The Lead CRC will serve as the primary point of contact for all study-related activities, working closely with a Principal Investigator (PI) to establish site operations, ensure compliance, and set the standard for clinical excellence.

Key Responsibilities:

Daily Operations & Participant Management

• Prepare for daily study visits by reviewing eSource and ensuring participant documents and study materials are complete and accurate.
• Serve as the main contact for participants—greet, consent, and guide them through study procedures while addressing any questions or concerns.
• Perform study-related procedures as needed, including phlebotomy and EKGs.
• Maintain accurate records in the Clinical Trial Management System (CTMS) and manage investigational products and study supplies.

Study Conduct & Compliance

• Manage all aspects of clinical trials from startup through closeout, including regulatory documentation, source data verification, and data entry.
• Ensure compliance with ICH-GCP, FDA, and IRB requirements and prepare for sponsor and FDA audits.
• Conduct quality checks on study data, regulatory binders, and source documentation to ensure audit readiness.

Site Development & Leadership

• Serve as the lead research professional on site, acting as the liaison between the PI, site staff, and sponsors.
• Train and mentor new CRCs and support staff as the team grows.
• Guide a new physician through research processes and requirements, fostering a culture of quality and compliance.
• Support recruitment efforts using EMR searches, outreach, and collaboration with clinic staff.

Strategic & Administrative Responsibilities

• Oversee document organization and tracking, ensuring all trial documentation is maintained accurately and securely.
• Lead or participate in sponsor and CRO meetings, audits, and monitoring visits.
• Assist in budget negotiation and contract management as the department grows.
• Participate in site process development and long-term operational planning.

Qualifications:

Required:

• Minimum of 3 years of experience as a Lead Clinical Research Coordinator or equivalent.
• Proven ability to manage all aspects of clinical trials from study startup to closeout independently.
• Experience with complex study protocols (beyond single-visit or vaccine studies).
• Strong understanding of FDA regulations, ICH-GCP guidelines, and clinical documentation standards.
• Excellent communication, organization, and problem-solving skills.

Preferred / Nice to Have:

• Phlebotomy and EKG experience.
• Experience supporting or leading sponsor or FDA audits.
• Experience working with research-naïve PIs.
• Familiarity with psychiatric rating scales, such as:
• MADRS (Montgomery–Åsberg Depression Rating Scale)
• SSTS (Structured Interview Guide for the Hamilton Depression Rating Scale)
• CGI (Clinical Global Impression)
• CSSRS (Columbia Suicide Severity Rating Scale)
• MOAA/S (Modified Observer's Assessment of Alertness/Sedation)

Why This Role Stands Out

• Be the
  founding member
  and leader of a new clinical research department.
• Gain
  direct mentorship and growth opportunities
  toward a future management position.
• Play a
  hands-on and strategic role
  —balancing participant care, operations, and leadership.
• Build a
  strong foundation
  for a site that values excellence, collaboration, and integrity.