IFS Technical Consultant providing technical solutions and support for customers in a hybrid role. Collaborating on integrations and custom developments using various technologies.
About the role
- Principal Investigator MD leading clinical trials in Springfield for Hawthorne Health. Overseeing research protocols and managing clinical research teams while ensuring regulatory compliance.
Responsibilities
- Accurately document findings and contribute to ongoing clinical trials, registries, or research protocols as applicable.
- Oversee and manage all aspects of clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements.
- Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff.
- Delegate study-related duties appropriately to qualified personnel and ensure proper training and oversight.
- Conduct remote review of patient assessments, including physical exams, medical histories, and eligibility screenings, to ensure appropriate participant enrollment.
- Review and interpret laboratory results, ECGs, and other diagnostic tests.
- Make critical medical decisions regarding participant care, adverse events, and protocol deviations.
- Ensure accurate, complete, and timely collection and documentation of all study data.
- Communicate effectively with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities.
- Manage investigational product accountability, storage, and administration according to protocol and with the help of the on-site IP team.
- Participate in site initiation visits, monitoring visits, audits, and inspections.
- Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas.
Requirements
- Experience as a Principal Investigator on at least 3 sponsor initiated clinical trials.
- Medical Doctor (M.D. or equivalent) degree from an accredited institution.
- Current, unrestricted medical license in Missouri.
- Board certification in a relevant specialty preferred.
- Demonstrated in-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research.
- Proven leadership and team management skills.
- Excellent clinical judgment and decision-making abilities.
- Strong verbal and written communication skills in English, with the ability to present complex information clearly and concisely.
- Exceptional organizational skills and meticulous attention to detail.
- Ability to manage multiple complex studies simultaneously and prioritize tasks effectively.
- Commitment to ethical conduct and patient safety.
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