Description
IQVIA Belgium is looking for a talented and motivated Clinical Research Associate (CRA) to join our Site Management team.
As a CRA, you will perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Your Responsibilities:
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- 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
- 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
- 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
Your Profile:
- University degree in scientific discipline or health care
- 2+ years of experience as a CRA
- Very good computer skills including MS Office
- Excellent command of Dutch, French and English language
- Organizational, time management and problem-solving skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Flexibility to travel
- Driver’s license class B
What You Can Expect:
- Resources that promote your career growth
- Leaders that support flexible work schedules
- Programs to help you build your therapeutic knowledge
- Excellent working environment in a stable, international, reputable company
- Company car, mobile phone and attractive benefits packaging