House Clinical Research Associate
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Site In-House Clinical Research Associate II – EMEA
Employment Type: Full-Time, 12-Month Fixed-Term Contract
Hours: 40 hours per week
Working Model: Site-based / In-house
Start Date: To be confirmed
Client: Leading Global Medical Device Organisation
About the Role:
We are currently building a pipeline for an exciting opportunity with a leading global medical device organisation for a Site In-House Clinical Research Associate II – EMEA, based in Brussels.
The Site In-House Clinical Research Associate II will support the planning, initiation, execution and closeout of clinical studies at assigned study sites. Working closely with the wider Clinical Research and Site Management teams, this role will help ensure studies are conducted in accordance with approved protocols, applicable regulations, Good Clinical Practice (GCP) and established company procedures.
The successful candidate will act as a key point of contact for assigned clinical sites, supporting site activation, ongoing study activities, regulatory documentation, data quality and issue resolution. The role will also involve collaboration with field-based clinical personnel, internal study teams and site staff across the clinical trial lifecycle.
This is an excellent opportunity for an experienced clinical research professional looking to work within a global medical device environment and contribute to the delivery of innovative clinical studies.
Key Responsibilities
- Support regulatory and clinical protocol compliance across assigned clinical studies and study sites.
- Coordinate the startup, maintenance and closeout of assigned clinical study sites in partnership with field-based and in-house clinical personnel.
- Act as the primary point of contact for assigned study sites and maintain effective relationships with site investigators and research teams.
- Support site activation activities, including collection, review and maintenance of required regulatory and study documentation.
- Review informed consent documents to ensure all required elements are present and appropriately documented.
- Review and analyse clinical study data and regulatory documentation for accuracy, completeness and compliance.
- Support the identification, tracking and resolution of data queries and documentation discrepancies.
- Follow up on findings identified during monitoring visits, audits and other quality activities, supporting timely resolution and appropriate documentation.
- Serve as a liaison between Clinical Study Management, Site Management and site personnel regarding protocol-related questions and issues.
- Escalate significant study, site, compliance or quality issues to the appropriate internal stakeholders.
- Support the implementation of clinical research processes and contribute to continuous improvement initiatives.
- Assist with training internal and external clinical professionals on study protocols, clinical processes and applicable procedures.
- Maintain accurate and up-to-date clinical trial information within internal systems and document management platforms.
- Collect, maintain and communicate regional and site-specific information required to support study activation and execution.
- Monitor site progress against study timelines and support the identification of potential delays or risks.
- Maintain effective communication with study teams and sites throughout the clinical trial lifecycle.
- Mentor and provide guidance to less experienced clinical team members where required.
- Act as a study champion for assigned projects where appropriate.
- Contribute to global and regional clinical research process improvement initiatives.
Required Qualifications & Experience
- Bachelor’s degree from an accredited university or college, preferably in Natural Sciences, Pre-Medicine, Nursing, Bioengineering or a related discipline.
- Minimum 5 years of relevant clinical research experience, or an equivalent combination of education and professional experience.
- Experience within the medical device industry is highly desirable.
- Strong understanding of clinical trial processes, including study startup, site activation, study execution and closeout.
- Good understanding of clinical research regulations, Good Clinical Practice (GCP) and clinical protocol requirements.
- Experience working directly with clinical research sites, investigators and research staff.
- Ability to review clinical and regulatory documentation for accuracy, completeness and compliance.
- Strong written and verbal communication skills.
- Excellent interpersonal and stakeholder management skills.
- Strong analytical and