You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
We are seeking a highly organized and experienced Clinical Research Supervisor to lead and support the execution of clinical trials. This role oversees clinical research coordinators, ensures compliance with study protocols and regulatory requirements, and serves as a key liaison between internal teams, sponsors, and regulatory bodies. The ideal candidate has strong leadership, operational, and clinical trial management skills, with a focus on quality, efficiency, and patient-centered care.
Key Responsibilities
- Supervise clinical research coordinators, ensuring efficient workload distribution, performance optimization, and adherence to all regulatory and protocol-specific requirements.
- Collaborate cross-functionally to design, implement, and refine workflows, processes, and standard operating procedures (SOPs) that support quality and efficiency in clinical trial operations.
- Manage site qualification, initiation, and close-out visits with study sponsors to support successful clinical trial execution.
- Review new study protocols and informed consent documents with staff to ensure understanding of study objectives, methodology, visit schedules, adverse event reporting, and safety monitoring.
- Oversee subject screening conducted by coordinators, ensuring eligibility assessments are thorough and based on medical history, current health status, and protocol-specific criteria.
- Ensure all study-related patient visits are conducted in compliance with protocol requirements, including clinical procedures, assessments, and testing.
- Supervise investigational product (IP) inventory, accountability, and reconciliation across sites in accordance with sponsor and regulatory expectations.
- Ensure accurate, timely, and complete data collection, documentation, and entry into sponsor systems and internal databases; verify that all activities meet protocol, regulatory, and institutional standards.
- Serve as a key liaison with sponsor representatives and monitors, addressing protocol inquiries and supporting monitoring visits.
- Lead the review and dissemination of protocol amendments, safety notices, suspensions, and terminations with direct reports.
- Liaise with sponsor staff such as study monitors and assist direct reports in preparing for and completing monitoring visits.
- Act as a subject matter expert and resource for staff regarding investigational product administration, safety profiles, and trial protocol specifics.
- Conduct feasibility assessments and assist with patient screening for enrollment as needed.
- Support sponsor audits, FDA inspections, and internal quality reviews through thorough preparation and participation.
- Uphold high standards of professionalism, confidentiality, and patient-centered care at all times.
- Perform other related duties as assigned to support departmental goals.
Qualifications
- 5 Years Minimum of Clinical Research Experience
- Must have Research Experience outside of an academic/Institution setting
- Must have Experience in a Supervisor or Manager role
- Must have Experience in Interventional Trials within Oncology Phase 2-4
- Manager of an Oncology Research Site in Industry (Preferred)
Skills
- Strong leadership and management skills
- Excellent communication and collaboration abilities
- Proficiency in clinical trials and regulatory compliance
- Operational and process improvement skills
- Bilingual proficiency in Italian
Additional Requirements
- Monday-Friday 8am-5pm with sometimes flexible schedule depending on trials
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
Our client 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, veteran status or any other characteristic protected by law.
*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.