Clinical Research Associate
4 weeks ago
We are seeking a highly skilled Clinical Research Associate to join our team at Boston Scientific. As a Clinical Research Associate, you will play a critical role in supporting 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.
The ideal candidate will have a strong background in clinical research, with experience in study submissions to the Ethics Committee in the UK, managing IRAS forms, NHS, and other applicable systems. You will be responsible for conducting clinical trial site start-up activities, including ethics committee submissions and approvals, site informed consent form customizations and negotiations, essential regulatory document collection, and collaboration with regulatory affairs for competent authority submissions and approvals.
You will also provide support in enrollment, follow-up, and closure of clinical trial activities, working independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection. The successful candidate will have excellent communication and problem-solving skills, with the ability to work in a team environment and manage multiple priorities simultaneously.
Responsibilities:- Conduct clinical trial site start-up activities, including ethics committee submissions and approvals, site informed consent form customizations and negotiations, essential regulatory document collection, and collaboration with regulatory affairs for competent authority submissions and approvals.
- Provide support in enrollment, follow-up, and closure of clinical trial activities.
- Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection.
- Manage multiple priorities simultaneously, including multiple studies and division portfolios.
- 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 coordinators, 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, and procedures.
- Bachelor's Degree, or an equivalent combination of experience and education.
- Experience in study submissions to the Ethics Committee in the UK: manage IRAS form, NHS, and all applicable systems.
- Fluency (written and spoken) in English, a 2nd language will be a plus and highly considered.
- 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.
- Must be comfortable interacting with clinical research site personnel via phone and email.
- 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.
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Clinical Research Associate
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeClinical Research AssociateAt Boston Scientific, we are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team. As a key member of our team, you will play a critical role in supporting the execution of clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with clinical...
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Clinical Research Associate
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeClinical Research AssociateAt Boston Scientific, we are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team. As a key member of our team, you will play a critical role in supporting the execution of clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with clinical...
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Clinical Research Associate
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeClinical Research AssociateAt Boston Scientific, we are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team. As a key member of our team, you will play a critical role in supporting the execution of clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with clinical...
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Clinical Research Associate
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeClinical Research AssociateAt Boston Scientific, we are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team. As a key member of our team, you will play a critical role in supporting the execution of clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with clinical...
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Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeClinical Research AssociateJoin Boston Scientific's Global Clinical Operations team as a Clinical Research Associate, supporting the development of innovative medical devices and therapies. As a key member of our team, you will be responsible for conducting clinical trial site start-up activities, ensuring regulatory compliance, and collaborating with...
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Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeAbout this role:We are seeking a highly skilled Clinical Research Associate to join our Global Clinical Operations team. As a Clinical Research Associate, you will play a critical role in supporting the preparation and approval of regulatory documents, ensuring compliance with service level agreements, legal and regulatory standards, and applicable company...
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Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeAbout this RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Boston Scientific. As a Clinical Research Associate, you will play a critical role in supporting the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology,...
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Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeAbout this RoleWe are seeking a highly skilled Clinical Research Associate to join our team at Boston Scientific. As a Clinical Research Associate, you will play a critical role in supporting the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology,...
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Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Full timeAbout this role:We are seeking a highly skilled Clinical Research Associate to join our team at Boston Scientific. As a Clinical Research Associate, you will play a critical role in supporting the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology,...
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Hemel Hempstead, Hertfordshire, United Kingdom Boston Scientific Corporation Full timeJob Title: In-House Clinical Research AssociateJob Summary:The In-House Clinical Research Associate will support the Global Clinical Operations Center of Excellence by conducting activities consistent with GCO's mission of building a world-class shared clinical technology, process innovation, and clinical operations team.Key Responsibilities:Conduct clinical...
