You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
Join our client as a Quality Control Team Leader in a pioneering role where you'll establish and lead a clinical research department. As the solo Clinical Research Coordinator (CRC), you'll balance hands-on trial responsibilities with leadership, guiding the growth of the department while ensuring rigorous quality in trial management.
Key Responsibilities
- Oversee the preparation and organization of trial documents and participant appointments, ensuring compliance with regulatory standards such as FDA and ICH-GCP.
- Perform phlebotomy and other procedures, being the main point of contact for participant interaction and support.
- Manage trial documentation and participant data, taking responsibility for recruitment through EMR systems.
- Guide and train new physicians and team members, taking on a mentorship role as the team expands.
- Conduct quality checks on data and files in preparation for audits and other compliance checks.
- Use the Clinical Trial Management System (CTMS) for tracking study progress and manage study supplies.
- Engage with high-level tasks like budget negotiation and contract management over time.
Qualifications
- At least 3 years of experience as a CRC managing complex protocols beyond basic vaccine trials.
- Ability to handle all clinical and regulatory components independently from site start-up through closeout.
- Proficient in phlebotomy and performing EKGs; prior experience with Sponsor or FDA audits is advantageous.
- Full on-site presence required, Monday–Friday, 9 am–5 pm.
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
This job description outlines the general nature and key responsibilities of the position. It is not intended to be a comprehensive listing of all responsibilities, duties, or skills required. Responsibilities, duties, and skills may vary depending on the needs of the working environment. Continued employment is contingent upon successful completion of all regulatory and background checks.
*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.
