.Job Description: Posted Date: Sep 19, 2024 Workmode: Hybrid Additional Locations: Spain-Madrid 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.
About the Role The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Centre 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 behaviours 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 enrolment, follow-up, and closure of clinical trial activities.
This role offers weekly hybrid working and can be based from any BSC hub location across Europe.
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 Forms (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