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Lead Clinical Research Investigator
2 months ago
American Composites LLC is seeking a Lead Clinical Research Investigator to join our team. This role is essential in overseeing clinical trials focused on complex metabolic and central nervous system conditions.
Position Type: Part-time, flexible hours per week.
Qualifications:
- Medical Degree (MD): Must be licensed to practice in California.
Location: The role requires on-site presence in designated areas.
Language Proficiency: Fluency in both Spanish and English is preferred.
Experience: A minimum of 3 years in clinical research is required.
The primary responsibilities of the Investigator include ensuring the protection of human subjects and their rights throughout the clinical trial process. This involves supervising the study team to confirm that all delegated tasks are executed in accordance with the study protocol, Good Clinical Practice (GCP), and federal regulations. The Investigator is also responsible for maintaining the integrity and validity of the data collected during the trials, ensuring adherence to Standard Operating Procedures (SOPs), GCPs, and International Council for Harmonisation (ICH) guidelines.
Key Responsibilities:
- Participate in site initiation visits and training for current protocols.
- Maintain an active medical license.
- Complete all required SOP training.
- Oversee and guide the clinical team in their assigned tasks.
- Assist in the recruitment process for clinical trials.
- Conduct informed consent processes in compliance with SOPs.
- Evaluate patient eligibility for clinical trials.
- 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.
- Other duties as assigned by management.
Education and Training:
A qualified candidate must possess a medical degree (MD) and have at least 3 years of clinical research experience.
Competency Requirements:
- Strong communication skills.
- Effective problem-solving abilities.
- Excellent organizational and planning skills.
- Customer service orientation.
Technical Competency:
In-depth knowledge of FDA-GCP regulations related to the protection of human rights and safety in clinical research.
Physical Requirements:
This position may require night and weekend work, and involves lifting up to 20 pounds.
About American Composites LLC:
American Composites LLC is dedicated to enhancing the quality of life through innovative scientific research. We are committed to addressing the challenges of patient recruitment and the complexities of clinical trials.
All applicants must be authorized to work in the United States. American Composites LLC is an equal opportunity employer and prohibits discrimination and harassment of any kind.
