You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
As a Clinical Research Coordinator specializing in GI and Hepatology, you will play a pivotal role in managing site operations from startup to execution. Serving as the primary point of contact, you will oversee the entire lifecycle of clinical trials, ensuring seamless communication between the clinic, Principal Investigator, and Sponsor.
Key Responsibilities
- Serve as the sole full-time representative managing interface between the clinic, the PI, and the Sponsor.
- Lead trial execution from A–Z for new site launches, ensuring site readiness and operational workflow establishment.
- Manage direct Sponsor communications and maintain professional relationships with the local clinic team.
- Oversee Phase II/III interventional protocols within GI and Hepatology, conducting informed consent, screening, and complex study visits.
- Maintain all site-level regulatory binders and ensure source data accuracy and audit readiness.
Qualifications
- 3–6 years of Phase II/III Sponsor-led trial experience.
- Expertise in phlebotomy, vitals, and patient assessments.
- Experience with GI or Hepatology protocols is preferred.
- Expert knowledge of GCP, FDA compliance, and "audit-ready" documentation.
Skills
- Proficiency in EDC, IRT/IWRS, and eTMF platforms.
- Exceptional skills in recruitment, informed consent, and retention for complex studies.
- Ability to act as the professional "face of the organization" for PIs and Sponsor monitors.
- Decisive action in startup environments to mitigate enrollment or operational delays.
Additional Requirements
Monday - Friday, 8 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
Medix is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, or genetics.
*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.
