Medix™
Lead Clinical Research Coordinator/Manager - 246850
Medix™, Los Angeles, California, United States, 90079
Lead Clinical Research Coordinator/Manager - 246850
Lead Clinical Research Coordinator/Manager
Schedule: Monday–Friday, 9:00 AM–5:00 PM (On-site)
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.
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 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:
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.
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr
Schedule: Monday–Friday, 9:00 AM–5:00 PM (On-site)
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.
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 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:
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.
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr