About this role
Job title: Experienced Clinical Research Associate - IQVIA Biotech
About the Role IQVIA Biotech is seeking an Experienced Clinical Research Associate to join the EU Clinical Monitoring team. The role supports monitoring of Phase I-IV trials, conducts site evaluation, initiation, and interim close-out visits, and ensures compliance with Good Clinical Practice and sponsor procedures. The position requires being based in the Netherlands and offers home-based work.
What You'll Do
- Participate in the preparation and execution of Phase I-IV clinical trials.
- Oversee progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites.
- Monitor clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors.
- Work closely with the Clinical Trial Manager and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.
- Participate in investigator recruitment processes, performing site evaluation visits to assess site capability.
- Coordinate activities with the site and internal departments in preparation for study initiation.
- Perform study initiation activities, reviewing protocol, regulatory issues, study procedures, and provide training on eCRF and EDC systems; monitor activities and study close-out.
- Assist in resolving issues to ensure compliance with site file audits in conjunction with ISS.
- Assure adherence to GCP, investigator integrity, and compliance with study procedures through on-site monitoring visits.
- Perform validation of source documentation as required by sponsor.
- Prepare monitoring reports and letters per timelines defined in IQVIA Biotech SOPs.
- Document accountability, storage conditions of clinical trial materials, and perform investigational product inventory.
- Review data quality and integrity through in-house review of electronic CRF data and on-site source verification; work with sites to resolve data queries.
- 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 investigators; coordinate all correspondence and ensure timely transmission of clinical data and reporting.
- Assist with, and attend, Investigator Meetings for assigned studies.
- Attend study-related, company, departmental, and other meetings as appropriate.
What We're Looking For
- Based in the Netherlands with ability to work remotely.
- Experience participating in investigator recruitment and site evaluation visits.
- Proven ability to coordinate initiation activities and monitor sites per study requirements.
- Strong knowledge of Good Clinical Practices and regulatory requirements.
- Experience with eCRF/EDC systems and training site personnel.
- Ability to perform on-site monitoring, data verification, and query resolution.
- Excellent communication and collaboration skills with Clinical Trial Managers/Lead CRAs and site staff.
- Capable of coordinating with internal departments to initiate studies and manage documentation.
Nice to Have
- Experience with IQVIA Biotech SOPs or Investigator Meetings.
- Familiarity with document management, site file audits, and protocol review processes.
Compensation & Benefits
- No salary range or benefits information provided in the posting.