Lead Clinical Research Investigator
2 weeks ago
The Catalina Research Institute (CRI), part of ACRS Holdings, is dedicated to advancing clinical trials focused on complex metabolic and central nervous system conditions. We are currently in search of a Clinical Research Principal Investigator.
Position DetailsWork Schedule:
Part-time or Full-time options available.
The ideal candidate must possess a valid medical license in California and be one of the following:
- MD: Doctor of Medicine
Fluency in both Spanish and English is preferred. A minimum of 3 years of clinical research experience is required.
Key ResponsibilitiesThe Principal Investigator's primary role is to ensure the protection of human subjects and uphold their rights throughout the clinical trial process. Responsibilities include:
- Overseeing the study team to ensure compliance with protocols, GCP, and federal regulations.
- Maintaining the integrity and validity of data collected during trials.
- Promoting adherence to SOPs, GCPs, ICH guidelines, and protocols.
- Participate in site initiation visits and training for all current protocols.
- Ensure current licensure is maintained.
- Complete necessary SOP training.
- Engage in all delegated study tasks and provide oversight to the clinical team.
- Assist in the recruitment process for clinical trials.
- Conduct informed consent processes in accordance with SOPs.
- Evaluate patient eligibility for trial inclusion.
- Document all relevant medical histories and adverse events.
- Review laboratory results and assess their clinical significance.
- Participate in monthly staff meetings and annual SOP reviews.
A qualified individual in the healthcare field (MD) with at least 3 years of clinical research experience is essential.
Specialized TrainingIn-depth knowledge of federal regulations regarding the responsibilities of a Principal Investigator is required.
Competencies- Exceptional communication skills.
- Strong problem-solving abilities.
- Effective planning and organizational skills.
- Customer service orientation.
Comprehensive understanding of FDA-GCP regulations related to the protection of human rights and safety in clinical research.
Physical and Environmental RequirementsWork is typically performed in a clinical/office environment with the possibility of night and weekend schedules. Lifting may be required up to 20 pounds.
About ACRS HoldingsACRS Holdings is committed to enhancing the quality of life for individuals through scientific research, focusing on improving efficiencies in clinical trials.
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