We are seeking a skilled and experienced Dermatologist to join our team as Principal Investigator at a clinical research site in Murfreesboro, TN. The primary focus will be planning, execution, and management of assigned clinical studies. Key responsibilities include clear and effective communication with clients, study directors, and technicians, as well as fostering a cross-functional, adaptable, and collaborative approach. The PI oversees the proper conduct of clinical trials at the trial site, ensuring compliance with all relevant protocols and regulations.
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
- 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 or board eligibility in Dermatology
- Medical licensure in Tennessee