Responsible for the medical care and medical decisions for assigned clinical trials in accordance with all regulatory requirements (Form FDA-1572, Qualified Investigator Undertaking (QIU) or similar) and regulatory guidelines, company policies and procedures.
1.Reviews protocols and ICFs for medical input and appropriateness
2.Ensures that informed consent is obtained and documented in accordance with GCP and the Declaration of Helsinki, prior to performance of any study-related procedures
3.Performs clinical assessments including history taking, physical examinations and ECG interpretation on study subjects as required
4.Determines eligibility of study subjects in clinical studies based on individual inclusion and exclusion criteria
5.Ensures ongoing eligibility of study subjects
6.Trains clinical physicians/sub-investigators and staff on assigned clinical trialsReviews and signs medical laboratory results, ECGs and adverse event reports related to studies
7.Completes all Serious Adverse Events (SAEs) as the qualified investigator and monitors subject, as required, to resolution
8.Liaises with Sponsor on SAEs, study medical issues and as may be required during study conduct
9.Monitors and ensures subject safety as required
10. Ensures availability for query resolution and chart review in a timely fashion
11. On call coverage as required for medical/safety purposes on assigned studies
12. Attends site initiation visits (SIVs) for assigned trials
13. Completes and/or reviews AE narratives, clinical study reports and case report forms (CRFs) for assigned trials
Performs all duties to medical, ethical and corporate standards, Promotes an environment which supports clinical excellence, Problem solves with colleagues in a positive and timely manner. Education: •Valid Ontario medical license with College of Physicians and Surgeons of Ontario, Certification in family medicine, CCFP or FRCP in specialty medicine, Current medical malpractice insurance coverage in place (e.g. CMPA), Attendance at ICH/GCP and drug regulatory courses required and Experience in clinical research as a qualified investigator required
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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