Clinical Research Coordinator III - Lead Coordinator at Stella Mental Health

Los Angeles, California, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Apr, 26

Salary

0.0

Posted On

28 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research Coordination, Leadership, Mentoring, Compliance, Quality Assurance, Problem-Solving, Organizational Skills, Communication Skills, CTMS Proficiency, GCP Knowledge, FDA Regulations, IRB Guidelines, Training, Inventory Management, Analytical Skills, Team Motivation

Industry

Mental Health Care

Description

About the role We are seeking an experienced and dynamic individual to join our team as a Clinical Research Coordinator III – Lead Coordinator. This advanced-level position is ideal for candidates with a proven track record in clinical research coordination, leadership capabilities, and a passion for mentoring and oversight within a clinical research setting. Position Purpose: The Clinical Research Coordinator III (Lead CRC) is a senior research professional who not only manages study operations but also serves as a leader and resource for the clinical research team. Working under the direction of the Principal Investigator (PI) [and Site Manager] if applicable, the Lead CRC ensures compliance, quality, and operational efficiency across all clinical trials conducted at the site. What you'll do ● Conduct clinical trial activities per protocol and FDA, ICH, GCP, GDP standards. ● Serve as the primary point of contact for day-to-day clinical trial operations and escalation of issues for CRC I and II staff. ● Provide mentorship, training, and support to junior CRCs, assisting with onboarding and ongoing development. ● Oversee the delegation of study tasks to ensure even distribution of workload and adherence to timelines. ● Coordinate cross-functional teams to ensure all pre-study, initiation, and ongoing trial activities meet sponsor and regulatory requirements. ● Develop and implement site-specific workflows and protocols to optimize efficiency and compliance. ● Independently manage complex trials, including those involving investigational products, high volumes, or unique challenges. ● Ensure adherence to Good Clinical Practice (GCP), FDA regulations, IRB guidelines, and sponsor protocols. ● Conduct routine quality assurance reviews of documentation, source data, and regulatory files, providing feedback for corrections or improvements. ● Facilitate site audits and sponsor monitoring visits, serving as the lead point of contact. ● Act as the primary liaison for sponsors, CROs, and regulatory bodies regarding study updates, issues, and corrective actions. ● Ensure study participants are supported and informed throughout the research process, addressing escalated concerns as needed. ● Monitor site performance metrics and propose improvements to enhance operational efficiency. ● Oversee inventory management for investigational products, study supplies, and equipment. ● Coordinate training and preparedness of staff for emergency unblinding or adverse event protocols. Other Responsibilities: ● Represent the site at Investigator Meetings (IM) and external conferences, providing post-meeting updates to the team. ● Perform other leadership duties as assigned. Qualifications ● Education: Bachelor’s degree preferred ● Experience: Minimum 3 years of clinical research coordination experience, including 1-2 years in a leadership or mentoring role. Extensive experience managing multiple, complex trials with minimal supervision. ● Certifications: Certified Clinical Research Coordinator (CCRC) or equivalent credential preferred. ● Other Qualifications: o Strong knowledge of GCP, FDA, and IRB regulatory requirements. o Proven ability to lead and motivate teams in a clinical research setting. o Excellent problem-solving, organizational, and communication skills. o Proficiency in CTMS and electronic regulatory systems (any vendor, preferred) Performance Requirements: ● Advanced knowledge of clinical trial operations, compliance, and documentation. ● Demonstrated leadership, with the ability to mentor and oversee multiple team members. ● Strong analytical skills for identifying and resolving study challenges. ● Proficiency in Microsoft Office, CTMS, and other clinical trial software. ● Ability to manage multiple priorities under tight deadlines. Benefits: ● Competitive salary commensurate with experience ● Comprehensive benefits package, including [Insert] ● Opportunities for professional development and leadership advancement ● Collaborative and supportive work environment with a focus on teamwork and innovation *Work Location: In person

Responsibilities

The Clinical Research Coordinator III (Lead CRC) manages study operations and serves as a leader for the clinical research team. They ensure compliance, quality, and operational efficiency across all clinical trials conducted at the site.