You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
The Principal Investigator is responsible for managing and overseeing clinical trials at a trial site. Our client's primary focus is ensuring the safety of study participants and maintaining the integrity of the conducted study and collected data. The role requires strict adherence to compliance with Good Clinical Practice (GCP), federal regulations, and ethical guidelines as per the company's Standard Operating Procedures (SOPs) and the study protocol.
Key Responsibilities
- Ensure the safety and welfare of study participants.
- Supervise the conduct of the clinical research study, even when responsibilities are delegated to other trained staff members.
- Oversee all trial-related medical decisions as outlined in FDA 1572 and/or HC QIU.
- Ensure compliance with regulatory body regulations, GCP, ethics, SOPs, and the sponsor protocol.
- Ensure all delegated staff are experienced and have documented training.
- Demonstrate potential for enrollment of subjects and following informed consent procedures as outlined in ICH & regulatory body regulations.
- Protect the rights, safety, and welfare of subjects enrolled in a clinical research trial.
- Familiarity with the appropriate use of investigational product(s) as per the protocol and other information sources provided by the sponsor.
- Maintain adequate study records and storage as per regulatory requirements.
- Maintain appropriate control, inventory, distribution, storage, record keeping, and destruction or return of test articles.
- Promptly report any unanticipated problems & risks to patients to sponsors, IRB, or Regulatory agencies as applicable.
- Ensure timely reporting of events requiring prompt reporting such as annual progress reports or major protocol deviations.
- Assure the disclosure of financial interest and arrangements to the sponsor and the REB.
Qualifications
- MD or NP, licensed to practice in Quebec.
- In good standing for practice.
Experience
- Preferred 1-5 years of research experience.
- ACLS Certification preferred.
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).
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.
*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 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.