The Principal Investigator will mentor, provide leadership, and educate the study team. He/she will provide medical oversight for specific clinical trials conducted at the site and work closely with the research team. He/She will ensure the medical well-being and safety of the participants through the safe performance and execution of the studies. He/she will coordinate with the Site Director and the Study Coordinator, ensuring compliance with the study protocol. He/She will ensure the trial is conducted in compliance with GCP, international and local regulations and the scientific integrity of the data generated at the site.
In this position, you will be expected to:
· Assist in maintaining clinical oversight and quality on the conduction of the studies and deliver on study milestones, thereby contributing to the commercial success of the site.
· Ensure the clinical trials are conducted according to the protocols, good clinical practice (GCP) standards and site SOPs.
· Ensure and protect the welfare and safety of participants through ethical conduct.
· Perform physical exams, diagnostics, interpret lab results, and assess the subject’s eligibility for the trials (ECGs, medical history, etc.…).
· Ensure proper informed consent has been obtained.
· Delegate investigational product (IP) administration to the delegated study team member.
· Support corporate quality and continuous improvement processes.
· Attend and participate in training, investigator meetings, relevant scientific meetings, and operational meetings for each study. Review the source document created for each study for completeness, accuracy, and good documentation practices according to the protocol, regulations, and therapeutic area.
· Train the study team on the study protocol, informed consent, source document and study procedures before the Site Iinitiation Visit.
· Ensure scientific integrity of data.
· Participate in the informed consent process actively or overseeing the process.
· Participate in recruitment activities, such as contacting referral physicians, planning educational campaigns, health fairs, social media posts, radio, TV, etc.
· Be available for participant visits, discuss any concern/questions with the subject or the physician in charge of the visit.
· Assure that the receipt, handling, accountability, storage, dispensing and return of the IP is done in a correct way, according to the sponsor’s direction.
· Ensure that adverse events are properly documented and reported, and that subject receives the appropriate medical care and follow-up.
· Support the pharmacy and laboratory staff as needed.
· Participate in sponsor/CRO monitoring visits as needed and assist the study coordinator in addressing queries.
· Perform end of study (EOS) activities such as physical examinations.
· Other activities as assigned.
EDUCATION AND EXPERIENCE
· Board Certified Internal Medicine, Family Practice, Infectious Disease preferred.
· MD or DO
· Minimum 1 year of experience in a healthcare position
· Previous experience in clinical research as investigator preferred but not required with vast knowledge of GCP/ICH guidelines, best practices in clinical research,and local regulations.
