Clinical Research Associate - Iqvia MedTech
Participates in the preparation and execution of medical Device clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, monitoring and close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA MedTech and sponsors. Works closely with the Clinical Project Manager (CPM) to ensure all monitoring activities are conducted according to study requirements.
- Participates 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.
- 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 provides training on completion of the eCRF and EDC system; monitoring activities and study close-out activities.
- Assists in resolving any issues to ensure compliance with site file audits
- 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 MedTech SOPs.
- Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory.
- Reviews 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 Project Manger
- Serves as primary contact between IQVIA MedTech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
- Assists with, and attends, Investigator Meetings for assigned studies.
- Attends study-related, company, departmental, and external meetings, as required.
- Ensures all study deliverables are completed per IQVIA MedTech and study timelines
KNOWLEDGE, SKILLS AND ABILITIES:
- By preference, you have a (para-) medical or scientific degree and at least one (1) year of clinical research experience including monitoring, or a minimum of two years of experience in pharmaceutical data management or as a study coordinator
- Fluent in English and Dutch/French, by preference in more languages;
- Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
- 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.
- The working conditions will involve regular up to intensive national and international travelling
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