Contract Clinical Research Associate (Oncology) (Saint-Nazai …, Saint-Nazaire-d'Acton

Overview The Clinical Research Associate will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Responsibilities - Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. - Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately escalates serious issues to the project team and develops action plans. - Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. - Demonstrate diligence in protecting confidentiality of each subject/patient. - Assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. - Verify the IP has been dispensed and administered to subjects/patients according to the protocol. - Verify issues or risks associated with blinded or randomized information related to IP. - Apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released/returned. - Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconcile contents of the ISF with the Trial Master File (TMF). Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. - Support subject/patient recruitment, retention, and awareness strategies. Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables and timelines are met. - Must be able to quickly adapt to changing priorities to achieve goals/targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings. Participate in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project specific requirements. - Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions. - Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required. Qualifications - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - Must demonstrate good computer skills and be able to embrace recent technologies. - Excellent communication, presentation, and interpersonal skills. - Ability to manage required travel of up to 65% on a regular basis. Education and Experience BS/BA (MS/MA is desirable) in a health-related field. Must have strong customer service orientation and be a proactive and effective communicator. Excellent interpersonal skills are imperative. Work Environment This job is a contract position. Equal Employment Chance This is an equal employment opportunity, and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status. Accommodations As provided by the Americans with Disabilities Act, the company is committed to discussing and providing reasonable accommodations to its employees to help them fulfill the essential functions of their jobs. Apply on Kit Job: kitjob.ca/job/2pse4e