Clinical Research Associate
il y a 1 mois
**Work mode**:Hybrid**Onsite Location(s)**:Diegem, BE**Additional Locations**: Belgium-Diegem**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**
- At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.- he Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world class shared clinical technology, process innovation and clinical operations team, in partnership with the company’s divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.- Driving principles and behaviors for this role are collaboration, accountability, innovation, adaptability, integrity and caring.- Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the CRA conducts **clinical trial site start-up activities** related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. Specifically, these activities will include:
- Ethics Committee (EC) submissions and approvals.
- Site informed consent form (ICF) customizations & negotiations.
- Essential regulatory document collection.
- Collaboration with Regulatory Affairs for Competent Authority (CA) submissions and approvals and other site start-up support activities, as applicable.
**The CRA also provides support in enrollment, follow-up, and closure of clinical trial activities**.**Your responsibilities will include**:
- Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.
- Manage multiple sets of essential regulatory documents across several studies and division portfolios.
- Partner with clinical sites to support the negotiation and customization of Informed Consent Form (ICF)
- Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.
- Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals.
- Develop, prepare, complete and track required regulatory, ICF and legal documentation.
- Document clinical research site and investigator readiness for participation across multiple studies
- Support internal quality audits, regulatory inspections, as applicable.
- Update and maintain study-specific startup and close out trackers.
- Update and maintain site specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs.
- Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc.
- Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate.
- Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures.
**What we are looking for in you**:
Minimum Qualifications- Bachelor’s Degree, or an equivalent combination of experience and education.
- 4-5 years experience in a CRA role
- Experience in study submissions to the Ethics Committee.
- Fluency (written and spoken) Dutch and English Mandatory. Any additional languauge is a plus.
- Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment.
- Ability to work in a team environment and possess clear, concise communication & presentation skills - written and verbal.
- Preferred Qualifications- Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate /Study Start up specialist experience.
- Experience working with Ethic Committee’s.
- Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF.
- This role offers weekly hybrid working mode and can be based from any BSC hub location across Europe.**Requisition ID**:591470- **Job Segment**:Clinical Research, Medical Research, Compliance, Regulatory Affairs, Healthcare, Legal, Research
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