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 skilled and dedicated Clinical Research Coordinator to oversee study activities, maintain regulatory compliance, and ensure adherence to protocols. This position involves coordinating study start-ups, managing documentation, and serving as the primary sponsor contact. The role requires assessing patient eligibility, tracking enrollment, and preparing for quality assurance audits.
Key Responsibilities
- Monitor study activities, maintain comprehensive regulatory files, and ensure strict adherence to protocols, FDA regulations, and institutional policies.
- Coordinate study start-ups, manage informed consent documentation, prepare protocol worksheets, and serve as the primary sponsor contact.
- Assess patient eligibility via medical records, track enrollment/retention, and record/report adverse events in consultation with investigators.
- Prepare for and participate in quality assurance audits, identify protocol deviations, and assist in timely problem resolution.
Qualifications
- 3+ years experience in research coordination and managing trial activities.
- In-depth working knowledge of GCP, GDA, and IRB requirements.
- Hands-on experience with clinical trial management systems (CTMS), EDC platforms, and Microsoft Office.
- Bachelor's degree in a related field.
- CCRC or CCRP designation.
Skills
- Technical skills in CTMS, EDC platforms, and Microsoft Office.
- Exceptional organizational, detailed communication, independent time management, and leadership skills.
- Experience utilizing EPIC EMR.
Additional Requirements
Monday-Friday, 8am-4:30pm with flexibility for early mornings (starting at 7:30am). Full-time onsite.
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
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.
