Lead Clinical Research Investigator

2 weeks ago

St Louis, Missouri, United States Denali Health Full time

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 maintaining the integrity, 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 ethical practices, and a fervor for promoting advancements in medical science.

Primary Responsibilities:

Pre-Study Duties:

  • Protocol Assessment: Evaluate study protocols and internal capabilities, provide constructive feedback to sponsors, and participate in critical meetings.
  • Regulatory Approvals: Authorize essential documentation required for study initiation.
  • Study Kickoff & Communication: Engage in study kickoff meetings to gain a comprehensive understanding of study expectations.
  • Participant Engagement & Screening: Clarify study details to participants, secure informed consent, assist in screening processes, and approve candidates for enrollment.

During/Post Study Duties:

  • Study Management & Participant Oversight: Conduct physical examinations, manage adverse events, analyze study data, and collaborate with sponsors regarding safety information.
  • Safety Documentation & Reporting: Prepare reports for Serious Adverse Events (SAEs), review and finalize Case Report Forms (CRFs), and ensure participant safety throughout the study duration.
  • CRF Review & Site Evaluations: Review and endorse CRFs, and assist in site evaluations, providing expert insights.

Additional Responsibilities:

  • Network Expansion: Facilitate business development and maintain a network of specialist physicians.
  • Sponsor Engagement: Represent Denali Health at sponsor meetings and medical conferences.
  • Training & SOP Formulation: Aid in the development of Standard Operating Procedures (SOPs), train personnel, and ensure clinical safety readiness at the site.

Qualifications:

Educational Background:

  • MD or DO degree is mandatory. A PhD in a related discipline may be considered.
  • Board certification in a pertinent medical specialty is preferred.

Professional Experience:

  • At least 2 years of experience as a Principal Investigator or Sub-Investigator in clinical trials.
  • Proficiency in multiple languages is advantageous.

Skills & Competencies:

  • Exceptional leadership and team management abilities.
  • Outstanding communication and interpersonal skills.
  • Thorough understanding of GCP, FDA regulations, and IRB processes.
  • Capacity to collaborate effectively with multidisciplinary teams.
  • Attention to detail and the ability to manage multiple tasks efficiently.

Benefits of the Role:

Flexible Work Options:

  • Conduct research within your own practice or at our facilities, providing you with the flexibility to choose the most suitable location.

Adjustable 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 eliminating barriers in research and bridging the gap from laboratory to market. We promote an inclusive environment that encourages independence and career advancement. Our organization values integrity, innovation, and excellence in clinical research.

Denali Health is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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