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 Principal Investigator who will be responsible for ensuring the conduct of clinical research trials and compliance with federal and industry guidance and regulations. The Principal Investigator will report to the Medical Director.
Key Responsibilities
- Act as the primary leader and authority for the clinical trial at the research site.
- Ensure ethical and legal responsibility for the well-being of all study participants and the validity and accuracy of the research data.
- Report adverse events in a timely manner and review sponsor provided safety reports as required.
- Provide documented training to Sub-Investigators and study team members on study protocol and changes during the course of the trial.
- Sign off on electronic case books as per study guidelines and review informed consent forms.
- Maintain protocol compliance on all clinical trials according to ICH-GCP, local regulations, and study protocol.
- Oversee IRB review of the study and ensure written IRB approval is obtained before initiating the study.
- Communicate openly with the research team, study sponsor, and CRO.
- Meet regularly with study assigned monitors and research team to discuss ongoing protocol, patient issues, and participation.
- Provide medical support to Sub-Investigators and study staff for protocol-related issues.
- Maintain essential documents and records necessary for the conduction of the study.
- Ensure the medical well-being and safety of the study participants.
- Participate and engage in driving the delivery of study goal targets, such as participant recruitment and retention.
- Other duties as assigned.
Qualifications
- MD/DO license in good standing.
- Board certification and knowledge of clinical trials, and experience with applicable clinical research regulatory requirements (i.e., GCP and ICH guidelines).
- Clinical research trials experience with at least 2 years as a Principal Investigator preferred.
- Knowledge of EDC systems and technology-enabled solutions (EMR/Health Record Experience, Hybrid trials) with respect to clinical trials.
- Willingness to obtain multi-state license if needed.
Additional Requirements
- Travel up to 100% to clinical trial sites will be expected, dependent on study requirements.
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 LanguageAll individuals must be legally authorized to work in the United States without sponsorship. Verification of employment eligibility will be required at the time of hire.
*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.