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    Clinical Research Principal Investigator

    Denali Health
    2+ years
    Not Disclosed
    Indianapolis
    10 Nov. 27, 2024
    Job Description
    Job Type: Full Time Education: MD/DO/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Opportunity: Principal Investigator (PI)
    Location: Flexible (Private Practice or Denali Health Facilities)
    Department: Clinical Research

    Job Summary:

    Denali Health is seeking an experienced and dedicated Principal Investigator (PI) to lead and manage clinical research studies. As the PI, you will be responsible for overseeing all aspects of study design, execution, and compliance to ensure the integrity, safety, and success of clinical trials. The ideal candidate will possess a strong clinical research background, a commitment to ethical standards, and a passion for advancing medical science.

    Key Responsibilities:

    Pre-Study Responsibilities:

    • Protocol & Feasibility Review: Assess the protocol and internal capabilities, provide feedback to the sponsor, and attend key meetings.
    • Regulatory Documentation: Sign off on essential study start-up documents.
    • Study Initiation & Communication: Participate in study initiation meetings to fully understand study requirements.
    • Subject Interaction & Screening: Explain the study to participants, obtain informed consent, assist in screening, and approve subjects for enrollment.

    During/Post Study Responsibilities:

    • Study Conduct & Subject Management: Perform physical exams, manage adverse events, review study data, and collaborate with sponsors on safety data.
    • Safety Reporting & Documentation: Submit reports for Serious Adverse Events (SAEs), review and finalize Case Report Forms (CRFs), and monitor subject safety throughout the study.
    • Case Report Forms & On-Site Reviews: Review and sign CRFs, assist in on-site reviews, and provide expert insights.

    Additional Responsibilities:

    • Network Development: Support business development and maintain a network of physician specialists.
    • Sponsor Interaction: Represent Denali Health at sponsor meetings and medical conferences.
    • Training & SOP Development: Assist in developing Standard Operating Procedures (SOPs), train staff, and ensure clinical safety preparedness at the site.

    Qualifications:

    Education:

    • MD or DO degree required. A PhD in a related field may be considered.
    • Board certification in a relevant medical specialty is preferred.

    Experience:

    • Minimum of 2 years of experience as a Principal Investigator or Sub-Investigator in clinical trials.
    • Proficiency in more than one language is preferred.

    Skills & Competencies:

    • Strong leadership and team management skills.
    • Excellent communication and interpersonal skills.
    • In-depth knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB processes.
    • Ability to work collaboratively with multidisciplinary teams.
    • Strong attention to detail and the ability to manage multiple tasks.

    Key Benefits of the Opportunity:

    • Flexible Work Arrangements:
      Conduct research within your private practice or at Denali Health facilities. The flexibility to choose the most convenient location for your work.

    • Adaptable Scheduling:
      Commitment typically requires 5-10 hours per week per study. Many study-related activities can be completed in a single day, with options for additional scheduling flexibility.

    • Compensation:
      Negotiable, based on experience and commitment.

    Why Denali Health?

    Denali Health is dedicated to accelerating therapeutic innovations and breaking down barriers in clinical research. We are committed to fostering an inclusive environment where professionals can grow, work independently, and make significant contributions to advancing medical science. If you are looking to be part of a dynamic team that values integrity, innovation, and excellence, Denali Health offers an exciting opportunity to shape the future of healthcare 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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    Bucharest |

    Makkah :

    Jeddah | King Abdullah Economic City | Khulais | Riyadh | Najran | Rabigh |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |