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English:

IQVIA Biotech is seeking a Clinical Research Associate II with Oncology monitoring experience based in Eastern Canada.  Must be bilingual in French and English.  

BASIC FUNCTIONS:

Participates in the preparation and execution of Phase I-IV clinical trials.  Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites.  Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors.  Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. This position may also serve as Lead CRA.

II ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

• Collaborates with the ISSC department 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 ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
• Trains site staff on the EDC system and verifies site computer system.
• Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
• Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor.  Performs investigational product inventory.  Ensures return of unused materials to designated location or verifies destruction as required.
• Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
• Perform SAE review and reconciliation
• May review protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager and/or Lead CRA.
• Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
• Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
• May assist with, and attend, Investigator Meetings for assigned studies.
• Attends study-related, company, departmental, and external meetings, as required.
• May serve as mentor for new clinical study monitors.
• Authorized to request site audits due to data integrity concerns.
• Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
• Ensure all study deliverables are completed per IQVIA Biotech and study timelines.

LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

The Lead Clinical Research Associate mayperform any of the following tasks:

• Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

• Collaborate with the ISSC department 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 ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

• Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
• Assists with, and attends, Investigator Meetings for assigned studies.
• Train site staff on the EDC system and verify site computer system.
• Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
• Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
• Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory.  Ensures return of unused materials to designated location or verifies destruction as required.
• Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.
• May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.
• May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
• Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.
• Assist the study management in identifying and generating changes in scope
• Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
• Authorized to request site audits due to data integrity concerns.
• Attend study-related, company, departmental, and external meetings, as required.
• Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
• Ensure all study deliverables are completed per IQVIA Biotech and study timelines
• Conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.
• Serve as mentor for junior CRAs and those new to the company and/or study.
• Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.
• Review and approve CRA travel expenses and time sheets.
• Perform other duties, as requested.

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of clinical research process and medical terminology.
• Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
• Good organizational and interpersonal skills.
• Ability to reason independently and recommend specific solutions in clinical settings.
• Ability to understand electronic data capture including basic data processing functions.
• Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
• Ability to qualify for a major credit card, rent an automobile

PHYSICAL REQUIREMENTS:

• Very limited physical effort required to perform normal job duties
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time

MINIMUM RECRUITMENT STANDARDS:

• BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc.) and a minimum of two (2) years of monitoring/site management experience is required; or an equivalent combination of education, training and experience.
• Must possess 2+ years of oncology and/or medical device experience.
• Experience in monitoring and/or coordinating clinical trials required.
• Must be able to travel domestically approximately 65%-85%.
• Valid driver���s license
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

• 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.

Comme nos équipes de recrutement sont mondiales, veuillez soumettre votre CV en anglais et en français.

As our hiring teams are global, please submit your resume in both English and French.