Clinical Research Associate
at Boston Scientific Corporation
Diegem, Vlaanderen, Belgium -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 16 Dec, 2024 | Not Specified | 22 Sep, 2024 | 4 year(s) or above | English,Presentation Skills,Email | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
Work mode: Hybrid
Onsite Location(s):Diegem, BE
Additional Locations: Belgium-Diegem; France-Voisins le Bretonneux; France-Île-de-France; Germany-Düsseldorf; Italy-Milan; Netherlands-Kerkrade; Netherlands-Kerkrade; Netherlands-Maastricht; Poland-Warsaw; Spain-Madrid; United Kingdom-Hemel Hempstead
Responsibilities:
- 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)
- Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies.
- Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.
- Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.
- 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.
REQUIREMENT SUMMARY
Min:4.0Max:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
BSc
Proficient
1
Diegem, Belgium