Managing the day to day responsibilities for Screening and Clinical conduct and provides treatment and care to all volunteers who meet study eligibility criteria and are enrolled in the clinical trial. The incumbent will also be responsible for monitoring the safety of all volunteers through health status assessments and the performance of safety requirements. This includes accurate, timely and organized completion of assigned tasks within the CPMA department in accordance with study protocols, directives, SOP’s, GCP and applicable regulatory requirements.
- Performs clinical assessments including taking medical history, physical examinations, and vital Sign/ECG interpretation on study subjects.
- Performs PAP tests as needed
- Determines initial eligibility of study subjects in clinical studies based on study specific requirements completed at screening.
- Supervises study subjects in clinical studies.
- Reviews and signs medical laboratory results, ECGs, and adverse event reports related to studies.
- Reports all Serious Adverse Events (SAEs) to the qualified investigator in a timely manner and participates in the completion of the SAE form
- Ensures availability for query resolution and chart review in a timely fashion
- Administration of Investigational Medicinal Product as required.
- Attends study orientation/logistics meetings prior to study start.
- Attends study initiation visit (SIV) meetings when requested
- Ensures informed consent is obtained and documented in accordance with GCP (Good Clinical Practice) prior to performance of any study-related procedures.
- May perform Sub-Investigator responsibilities as assigned and delegated
- Ensures ongoing eligibility of study subjects.
- Other duties as assigned
- Current practicing registration as a Nurse Practitioner with the College of Registered Nurses of Ontario and relevant clinical experience is preferred.
- Current BCLS & First Aid certification, ACLS & GCP is an asset.
- Excellent command of the English language is required.
- Previous CRO experience is preferable.
- Ability to interact with colleagues and volunteers on a professional level.
- Ability to organize and maintain manual information sources, files and automated systems for storage and retrieval of data.
- Intermediate computer skills.
- Ability to respond quickly and efficiently in an emergency situation.
- Provide analytical support to protocol review meeting.
- Excellent verbal, written and interpersonal skills are required.
- Strong team player.
- Must be able to effectively communicate with colleagues and study volunteers as well as follow written instructions.
- Acute care experiences an asset. 12-Lead ECG interpretation.
- Ability to multitask in a fast-paced environment and adapt to changing priorities.
- Must be able to accommodate a flexible work schedule.