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Lead Clinical Research Investigator
2 months ago
Position Overview:
Denali Health is in search of a skilled and knowledgeable Lead Clinical Research Investigator to spearhead and oversee clinical research initiatives within our organization. The Investigator will play a crucial role in ensuring the quality, safety, and efficacy of clinical trials by managing all facets of study design, implementation, and regulatory compliance. The ideal candidate will possess a robust background in clinical research, a dedication to maintaining the highest ethical standards, and a fervor for advancing medical knowledge.
Core Responsibilities:
Pre-Study Duties:
- Protocol Evaluation: Review study protocols and assess internal capabilities, provide constructive feedback to sponsors, and participate in critical meetings.
- Regulatory Approvals: Authorize essential documentation required for study initiation.
- Study Kick-off & Communication: Engage in study initiation discussions to thoroughly comprehend study requirements.
- Participant Engagement & Screening: Clarify study details to participants, secure informed consent, assist in screening processes, and approve candidates for participation.
During/Post Study Duties:
- Study Execution & Participant Oversight: Conduct physical examinations, manage adverse events, analyze study data, and collaborate with sponsors regarding safety information.
- Safety Reporting & Documentation: Prepare reports for Serious Adverse Events (SAEs), review and finalize Case Report Forms (CRFs), and ensure participant safety throughout the study.
- Case Report Forms & On-Site Evaluations: Review and endorse CRFs, and assist in on-site evaluations, providing expert insights.
Additional Duties:
- Network Building: Aid in business development and maintain a network of medical specialists.
- Sponsor Engagement: Represent Denali Health at sponsor gatherings and medical symposiums.
- Training & SOP Formulation: Contribute to the development of Standard Operating Procedures (SOPs), train personnel, and ensure clinical safety readiness at the site.
Qualifications:
Education:
- MD or DO degree is mandatory. A PhD in a related discipline may be considered.
- Board certification in a pertinent medical specialty is preferred.
Experience:
- At least 2 years of experience as a Principal Investigator or Sub-Investigator in clinical trials.
- Proficiency in multiple languages is preferred.
Skills & Competencies:
- Exceptional leadership and team management abilities.
- Outstanding communication and interpersonal skills.
- Comprehensive knowledge of GCP, FDA regulations, and IRB processes.
- Capability to collaborate effectively with multidisciplinary teams.
- Attention to detail and ability to manage multiple tasks efficiently.
Key Benefits:
Flexible Work Options:
- Conduct research within your own practice or at our facilities, allowing you to choose the most suitable location.
Adaptable Scheduling:
- Commitment typically requires 5-10 hours per week per study. Many study-related tasks can be completed in a single day, with options for additional scheduling flexibility.
Compensation:
- Negotiable based on experience and qualifications.
About Denali Health:
Denali Health is dedicated to accelerating therapeutic innovations by addressing the challenges in research and bridging the gap from laboratory to market. We promote an inclusive environment that fosters independence and career advancement. Our organization values integrity, innovation, and excellence in clinical research.
Denali Health is an equal-opportunity employer, celebrating diversity and committed to creating an inclusive workplace for all employees.
