The Principal Investigator is responsible for personally conducting or supervising the conduct of human-subjects research and for protecting the rights, safety, and welfare of subjects enrolled in research programs. In this unique position the Investigator will work very closely with various medical and regulatory Sponsor personnel (Pharmaceutical, Biotechnology, Medical Device companies) in their product research and development process.
Oversees the conduct of clinical studies to ensure adherence to the research protocol/investigational plan, FDA regulation and guidelines, ICH/GCP, and the Optimal Research Standard Operating Procedures.
Review and evaluate research protocols and provide medical and scientific feasibility of all new Sponsor inquiries. Liaise with Sponsor regarding study design and site capabilities.
Review and understand information in the Investigator’s brochure, inclusive of potential risks and side effects of the investigational product.
Assist clinical operations and sales/marketing efforts with Sponsor visits.
Delegate study procedure responsibilities to clinical and administrative staff as necessary. Ensure that all team members are informed of their obligations in meeting study protocol and Sponsor commitments.
Interact with regulatory bodies as relevant to clinical operations.
Participates in site qualification visits, site initiation visits, and investigator’s meetings for assigned clinical trials (may involve travel) Attend Sponsor Investigator Meetings.
Perform research protocol procedures which may include, but are not limited to: physical examinations; review lab data; ECGs; medical history; evaluate inclusion/exclusion; study dosing; and other medical information to ensure volunteers are medically and mentally fit upon entering the research program.
Documents research related examinations, procedures, tests, and other activities in appropriately maintained source documents.
Determine causality of expected or unexpected results associated with investigational product and inform IRB and Sponsor as appropriate of relevant events.
Weekend and off-hours work as necessary.
Communicate with the Sponsor Representative and Principal Investigators regarding study activities as necessary.
Available to participate in Sponsor initiated monitor visits and quality assurance audits for periodic reviewing and querying of collected data as needed.
Communicate with Chief Medical Officer on a regular basis.
Maintain medical licensure, and any other relevant federal, state, and local licenses.
Perform all other duties as assigned.
Ability to read, write, and interpret the English language.
Medical Degree (MD) or Doctor of Osteopathy (DO)
Current state medical license in Texas
Minimum of three (3) years of clinical research experience
Knowledge of ICH/GCP guidelines, research protocol design and IRB.
Demonstrated leadership and management skills.
Self starter with experience working in a team environment
Ability to prioritize and organize a high volume workload and changing priorities
Good interpersonal, written, and verbal communications skills
Olorum, sequi ad magnati nvenist ibusciis aut rae. Eritect ibusandandem hilitiam imus por simolest, iscieni moloreped quamus, velesedi totatemodis del il il ium experum erestio. Nam que sandebit volorestium dolor si toriae.