You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Our client is seeking a Quality Control Team Leader who will play a pivotal role in their clinical trials. The primary responsibilities include leading and managing clinical trial operations, developing new staff, and moving toward a managerial position in the future. An emphasis on quality, regulatory experience, and the ability to oversee complex trials is essential.

Key Responsibilities

• Conduct clinical trial activities per protocol and FDA, ICH, GCP, GDP standards.
• Serve as the primary point of contact for clinical trial operations and escalation of issues.
• Provide mentorship, training, and support to junior CRCs.
• Oversee the delegation of study tasks and ensure adherence to timelines.
• Coordinate cross-functional teams for pre-study, initiation, and trial activities.
• Develop and implement site-specific workflows to optimize efficiency and compliance.
• Manage complex trials and ensure adherence to GCP, FDA regulations, IRB guidelines, and sponsor protocols.
• Conduct routine quality assurance reviews of documentation and regulatory files.
• Facilitate site audits and sponsor monitoring visits as the lead point of contact.
• Act as the primary liaison for sponsors, CROs, and regulatory bodies.

Qualifications

• 3-5 years of Lead CRC experience; site manager experience is a plus.
• Regulatory experience; experience with DEA is advantageous.
• Experience through an Audit, FDA, or sponsor is a plus.
• Comfortable with a Clinical Trial Management System, with CRIO experience preferred.
• Phlebotomy experience is beneficial.

Additional Requirements

• Excited to work with a research-naive physician and help guide them.
• Active recruitment through EMR and involvement in educational initiatives.
• Some travel may be required for conferences or Investigator Meetings.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

Required Employment / Compliance Language

Medix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.