Job Description

Job Responsibilities:

• Provide overarching medical direction and review of study protocols in alignment with the investigational plan and Good Clinical Practice (GCP).
• Offer medical expertise and assess scientific feasibility for new sponsor inquiries.
• Safeguard the safety, rights, and well-being of all study participants at the trial site.
• Ensure the integrity, accuracy, and credibility of clinical data collected at the site.
• Protect the confidentiality and personal integrity of participants throughout the study.
• Collaborate with and support clinical operations, research teams, and sponsor representatives as needed.
• Review and/or obtain participants’ medical histories in accordance with study requirements.
• Conduct physical examinations, assessments, and study-related procedures per protocol.
• Evaluate and interpret clinical findings, including diagnostic tests such as ECGs, lab results, and imaging.
• Promptly report Serious Adverse Events (SAEs) and any participant safety concerns to the sponsor and IRB as per protocol-specific guidelines.
• Oversee the administration and accountability of the Investigational Product (IP).
• Review, understand, and comply with the study protocol and all regulatory requirements.
• Maintain comprehensive, accurate, and timely documentation consistent with source data.
• Ensure IRB approval of all study-related documents (protocol, consent forms, recruitment materials) prior to study initiation and throughout its duration.
• Provide the IRB with essential product information, including the Investigator’s Brochure or Product Monograph, to support risk assessment.
• Notify the IRB of protocol amendments, safety updates, deviations, and unanticipated issues during the study.
• Remain fully informed on the proper use and safety profile of the investigational product as described in sponsor-provided materials.
• Adhere to all applicable regulatory requirements and ICH-GCP standards.
• Maintain and archive essential study documents in accordance with regulatory guidelines, including retention for at least two years post-study conclusion or product discontinuation.
• Participate in monitoring visits, sponsor meetings, and regulatory inspections, and grant access to all relevant study records.
• Ensure participants receive appropriate care and follow-up in the event of premature study termination or suspension.
• Provide detailed written communication to the IRB and sponsor in the event of study termination or suspension initiated by the investigator.

Job Requirements:

• Must have previous research experience.
• Onsite - part time position in St. Louis, MO
• Principal Investigator will be reporting to site Director at the location
• Exceptional written and verbal communication skills for report writing and presenting findings.
• Proven ability to lead a team and manage priorities in a fast-paced setting.
• Keen attention to detail and a strong commitment to maintaining confidentiality with sensitive information.

License/Certification:

• Minimum qualifications include an M.D or D.O with an active medical license
• Board certification in Family Medicine, Internal Medicine or Primary Care (Prefer Board certification or board eligibility in Dermatology)
• Medical licensure in Missouri

Job Tags

Similar Jobs