CLASSEMENT (É.-U.) :

Ce poste est classé comme exempté en vertu de la Fair Labor Standards Act (loi sur les normes du travail équitable); les salariés ne sont pas admissibles à la rémunération des heures supplémentaires.
Niveau d’emploi :
143
Emplacement d’affichage principal :
Kirkland, Canada (CAKRKR, 37,5, H)
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Senior Clinical Research Associate, Oncology – Francophone (Eastern Canada), IQVIA

Internal Job Description

• 3 years of experience in follow-up;

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong knowledge of the clinical research process, including working knowledge of clinical trial functional areas and medical terminology.
• Four years or more of experience in oncology and/or medical device.
• Experience in monitoring and/or coordinating clinical trials is mandatory.
• Excellent written and verbal communication skills to express complex ideas to study staff in research and clinical institutions.
• Demonstrated ability to form strong functional relationships.
• Excellent presentation, organizational, and interpersonal skills.
• Ability to interact with staff hierarchy to coordinate/execute study activities.
• Ability to manage multiple priorities across multiple and complex trials.
• Ability to reason independently and recommend specific solutions in a clinical setting.
• Ability to work independently, prioritize and work in a matrix team environment.
• Ability to mentor and co-monitor other CRAs as required.
• Knowledge of electronic data entry, including basic data processing functions.
• Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
• Able to qualify for a major credit card, lease an automobile.
• For the role of the Technical CTA, the CRA must have a thorough understanding of IQVIA systems with the ability to learn more.

PHYSICAL REQUIREMENTS:

• Very limited physical effort required to perform normal tasks
• Extensive use of the telephone and face-to-face communication requiring accurate speech perception
• Heavy keyboard use requiring repetitive finger movements
• Regular sitting for long periods of time

ESSENTIAL DUTIES, DUTIES AND RESPONSIBILITIES OF THE POSITION:

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• Participates in the investigator recruitment process. Conducts on-site evaluation visits of potential investigators. Evaluates the site’s ability to successfully manage and conduct the clinical study.

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• Collaborates with ISS to coordinate activities with the site in preparation for the launch of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with the ISS and site staff to obtain regulatory approval (IRB/IEC) of study-specific documents.

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• Conducts study initiation activities, reviews protocol, regulatory issues, study procedures with site staff, and provides training at the end of FERC; monitoring activities and study closure activities.

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• Trains site staff on the EDC system and verifies the site’s computer system.

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• Helps resolve any issues to ensure compliance with site file audits in collaboration with the ISS.

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• Ensures adherence to good clinical practices, investigator integrity, and adherence to study procedures through on-site monitoring visits. Performs validation of source documentation as per sponsor’s requirements. Prepares monitoring reports and letters according to the timelines defined in IQVIA SOPs using templates and reports approved by IQVIA or the Sponsor.

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• Documents the responsibility, stability, and storage conditions of clinical trial material as required by the sponsor. Conducts inventory of investigative products. Ensures the return of unused materials to the designated location or verifies destruction, if applicable.

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• Examines the quality and integrity of clinical data through (1) an internal review of the FIU’s electronic data and (2) an on-site source verification. Works with sites to resolve data queries.

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• May review protocols, FERCs, study manuals, and other related documents, as requested by the clinical trial authority and/or the lead CRA.

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• Serves as the primary contact between IQVIA and the investigator; coordinates all correspondence; Ensures timely transmission of clinical data with study site and technical reports as requested.

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• Conducts study closure visits in accordance with the study-specific clinical follow-up plan, including reconciliation and disposition of final investigation products, reconciliation of site study files, resolution of data queries up to database locking, and resolution of outstanding action items.

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• Attends and participates in investigators’ meetings for assigned studies.

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• Is allowed to request site audits due to data integrity issues.

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• Attends study, business, department, and outside related meetings as required.

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• Ensures that internal and study-related trainings are completed in accordance with IQVIA and/or study’s schedules; DECs should always be updated with relevant site updates/contacts.

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• Ensures that study deliverables are completed according to IQVIA Biotech and study schedules.

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• Conducts field assessment visits and field training of RCAF I, II and other core RCAs.

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• Serves as a mentor for CRA assistants and those who are new to the business and/or study.

• Performs other duties, as requested.
• You will be required to support, liaise with and/or work with IQVIA customers and/or suppliers across Canada and around the world therefore, a functional knowledge of English, both written and spoken, is necessary to perform the duties of this position.

ESSENTIAL DUTIES, DUTIES AND RESPONSIBILITIES OF THE SENIOR CRA POSITION:

The Senior Clinical Research Associate will be able to perform the following duties:

• Participates in the investigator recruitment process. Conducts on-site evaluation visits, as appropriate, of potential investigators. Evaluates the site’s ability to successfully manage and conduct the clinical study.
• Collaborate with ISS to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with the ISS and site staff to obtain regulatory approval (IRB/IEC) of study-specific documents.
• Conducts study launch activities, review with site staff protocol, regulatory issues, study procedures, and provide training at the end of the eCRF; follow-up and closure activities of the study.
• Attends and participates in investigators’ meetings for assigned studies.
• Trains site staff on the EDC system and checks the site’s computer system.
• Assist in troubleshooting issues to ensure compliance with site file audits in collaboration with the ISS.
• Ensures adherence to clinical best practices, investigator integrity, and adherence to study procedures through follow-up site visits. Performs validation of source documentation as per sponsor’s requirements. Prepares monitoring reports and letters according to the timelines defined in IQVIA SOPs using templates and reports approved by IQVIA or the Sponsor.
• Documents the responsibility, stability, and storage conditions of clinical trial material as required by the sponsor. Conducts inventory of investigative products. Ensures the return of unused materials to the designated location or verifies destruction, if applicable.
• Examines the quality and integrity of clinical data through (1) an internal review of the FRC’s electronic data and (2) an on-site source verification. Works with sites to resolve data queries.
• May review draft protocols, FERCs, follow-up reports and letters, study manuals and others, prepare study-related documents and templates, as requested by the CTA and/or ED.
• May serve as the primary contact between IQVIA Biotech and the investigator; coordinates correspondence; Ensures timely transmission of clinical data with study site and technical reports as requested.
• Assists the DEC and/or DE in reviewing project budgets, tracking costs, potential overruns and proposing/implementing cost-effective solutions.
• Assists study management in identifying and generating scope changes.
• Conducts study closure visits in accordance with the study-specific clinical follow-up plan, including reconciliation and disposition of the final investigational product, reconciliation of study files from the site, resolution of data queries up to database locking, and resolution of outstanding action items.
• Is allowed to request site audits due to data integrity issues.
• Attends study, business, department, and outside related meetings as required.
• Ensures that internal and study-related trainings are completed in accordance with IQVIA and/or study’s schedules; CTAs should always be updated with relevant site updates/contacts.
• Ensures that study deliverables are completed according to IQVIA and study schedules.
• May conduct field assessment visits and field training of RCAF I, II and senior RCAF.
• Serves as a mentor for ARC assistants and those who are new to the business and/or study.
• Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of a potential CRA.
• Reviews and approves CRA travel expenses and timesheets.
• Performs other duties, as required.

ESSENTIAL DUTIES, DUTIES AND RESPONSIBILITIES OF THE TECHNICAL CDS POSITION:

The technical DEC will be able to perform one of the following tasks for oncology studies:

• Bring together treatment-discharged and out-of-study patients.
• Generate and review various IL2 reports.
• Work closely with the CRDC to ensure that data is further reviewed and that discrepancies are documented.
• The Technical CTA may participate in the review of the CRDC and assist in the review of the patient’s profile, if necessary.
• Additional follow-up may be required following the CRDC review.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement