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Lead Clinical Research Investigator
2 months ago
The Catalina Research Institute (CRI), a subsidiary of ACRS Holdings, is dedicated to advancing clinical trials focused on complex metabolic and central nervous system conditions. We are currently seeking a Clinical Research Principal Investigator.
Work Schedule:
Part-time role: hours per week
Full-time role: hours per week
Qualifications:
The ideal candidate must hold a valid medical license in California and be one of the following:
- MD: Doctor of Medicine
Fluency in both Spanish and English is preferred. Candidates should possess a minimum of 3 years of experience in clinical research within the healthcare sector.
Key Responsibilities:
- Ensure the protection of human subjects and their rights throughout the clinical trial process.
- Oversee the study team to guarantee compliance with protocols, Good Clinical Practice (GCP), and federal regulations.
- Maintain the integrity and validity of data collected during clinical trials.
- Promote adherence to Standard Operating Procedures (SOPs), GCPs, and ICH guidelines.
Specific Duties Include:
- Participate in site initiation visits and training for current protocols.
- Maintain an active medical license and complete necessary SOP training.
- Engage in all study tasks delegated to team members.
- Possess comprehensive knowledge of company SOPs and ICH GCP guidelines.
- Guide and mentor the clinical team.
- Assist in the training of support staff involved in clinical trials.
- Facilitate patient recruitment for clinical trials.
- Schedule patient visits as needed, including weekends and holidays.
- Conduct informed consent processes in accordance with SOPs.
- Evaluate patient eligibility for clinical trial inclusion.
- Document medical histories, medication usage, and adverse events accurately.
- Review lab results and provide clinical significance for any abnormalities.
- Assess adverse events and drug reactions, documenting details thoroughly.
- Participate in monthly staff meetings and annual SOP meetings.
- Fulfill additional responsibilities as assigned by management.
Education and Experience:
A qualified individual in the healthcare field (MD) with at least 3 years of clinical research experience.
Specialized Training:
In-depth knowledge of federal regulations governing the responsibilities of a Principal Investigator is essential. The Investigator must be capable of managing projects effectively and understanding the information provided in the investigator's brochure, including potential risks and side effects of investigational products.
Competency Requirements:
- Exceptional communication skills.
- Strong problem-solving abilities.
- Effective planning and organizational skills.
- Customer service orientation.
Technical Competency:
Thorough understanding of FDA-GCP regulations related to the protection of human rights and safety in clinical research.
Physical and Environmental Requirements:
Work is typically performed in a clinical/office environment, with the potential for night and weekend hours. Lifting may be required up to 20 pounds or more.
About ACRS Holdings:
ACRS Holdings is committed to enhancing the quality of life for millions through scientific research, addressing challenges in patient recruitment and the complexities of clinical trials.
All employees must be authorized to work in the United States. ACRS is an equal opportunity employer, promoting diversity and prohibiting discrimination in all forms.
