CRA and Senior Clinical Research Associate
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Participate in the preparation and execution of Phase I-IV clinical trials for multiple sponsors. Oversee the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitor clinical trials in accordance with Good Clinical Practice and procedures set forth by IQVIA Biotech and sponsors. Work closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.
• Participate in the investigator recruitment process, performing site evaluation visits of potential investigators to evaluate the capability of the site to successfully manage and conduct the clinical study.
• On site approximately 8 days per month.
• Coordinate activities with the site and internal departments in preparation for the initiation of the study. Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provide training on completion of the eCRF and EDC system; monitoring activities and study close-out activities.
• Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
• Assure adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Perform validation of source documentation as required by sponsor. Prepare monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs.
• Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Perform investigational product inventory.
• Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification and works with sites to resolve data queries and produce robust data.
• May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
• Serve as primary contact between IQVIA Biotech and investigator; coordinate all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
• Assist with, and attends, Investigator Meetings for assigned studies.
• Attend study-related, company, departmental, and external meetings, as required.
• Ensure all study deliverables are completed per IQVIA Biotech and study timelines
• Conduct Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
• Serve as mentor for junior CRAs and those new to the company and/or study.
Knowledge, Skills and Abilities:
• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
• Have at least 12 months of independent on-site monitoring experience.
• Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
• Fluency in English and French
• Be flexible with the ability to travel nationwide
• Hold a full and clean driving license
• Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
• Able to handle several priorities within multiple, complex trials.
• Able to reason independently and recommend specific solutions in clinical settings.
• Able to work independently, prioritize, and work within a matrix team environment.
• Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
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