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, you will lead the study team and be responsible for the execution of complex clinical trials from study design through study closeout. The role includes business and financial management of our research site, as well as oversight of day-to-day operations.
Responsibilities / Job Duties
- Perform daily oversight and business management of all trials from start to study closure.
- Coordinate, monitor, and supervise all aspects of clinical studies from start-up to closeout.
- Prepare and maintain administrative logs and trackers, including various study-related trackers.
- Package, label, process, and ship specimens, and manage study visit and document tracking.
- Serve as the primary contact for sponsors regarding new studies and submissions.
- Perform oversight of clinical activities and site management processes.
- Manage trial feasibility processes and oversee site capability assessments.
- Ensure trials follow ICH/GCP standards and SOPs.
- Participate in the review of clinical data for QA and IRB regulatory audits.
- Assist regulatory staff in maintaining accurate information in regulatory documents.
- Review clinical monitoring reports and implement corrective actions.
- Oversee and lead patient recruitment, advertising, screening, and enrollment.
- Lead research staff to meet deadlines and support quality and profitability.
- Track budgets and report expenses for budget forecasting.
- Oversee the drafting of site materials, including training manuals and support documentation.
- Evaluate and revise protocols and clinical regulatory documents.
- Lead weekly staff meetings on various operational aspects.
- Conduct interviews, hiring, and reviews for the study team.
- Ensure proper use and maintenance of study equipment.
Minimum Education and Experience Qualification Requirements
Education
- B.A./B.S. degree in Health Sciences or related field, or equivalent combination of education and experience.
Qualifications
- 2+ years of experience in coordinating clinical trials.
- Licensed Phlebotomist/Vaccination administration.
- Relevant experience across multiple development phases and study lifecycles.
Skills
- Excellent organization and attention to detail.
- Quick and eager learner.
- Ability to work independently.
- Strong critical thinking skills.
- Professional demeanor.
- Excellent oral and written communication skills.
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.
*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).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on 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.
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.