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Clinical Research Associate - Monitor UK Job

Remote Eligible:  Remote in Country
Onsite Locations(s): 

Hemel Hempstead, GB

Additional Locations:  United Kingdom-Hemel Hempstead

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Boston Scientific transforms lives through innovative medical solutions that improve the health of more than 30 million patients around the world each year. 
We’re at the forefront of the medical device industry – leading, evolving it to address unmet and emerging needs in healthcare. 
Our culture powers our performance and we turn our shared vision into value with the contribution of our 36.000 colleagues around the world. 


Clinical Research Associate - Monitor UK


At Boston Scientific, you will have the opportunity to put your expertise into practice by delivering breakthrough services and solutions that create value for patients, customers and employee. You will be part of an agile and high performing team committed to advance science for life. That’s why we say that a career with Boston Scientific is more than just a job, it’s personal.


About the role:


Monitors progress of clinical studies at the site level to verify that the rights and well being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides support in start up, enrollment, follow up and closure of clinical trial activities.


Key Responsibilities:


  • Source Verification: conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records.  Issue, investigate and resolve data discrepancies.
  • Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
  • Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification and training records.
  • Site Compliance: ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required.
  • Event Reporting: ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
  • Collaboration: participates in study-specific meetings, teleconferences and trainings. Collaborates with cross-functional team members and study sites throughout all study phases.
  • Documentation: Manages study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database. Performs budget negotiations.
  • Performing study compliance oversight by conducting Site Compliance meetings; including data analysis to identify potential compliance outliers and work with the study teams and sites to resolve these issues.
  • Providing Site Management input to the study team during all phases of the study from study design, start up, enrolment, follow up and close out.
  • Provide review and feedback to Protocol design.
  • Helps develop Site Initiation Visit Material and trains monitoring team.
  • Helps develop Monitoring plans.


What we’re looking for in you:


  • Monitoring experience including experience as a Lead monitor, ideally within a Risk Based Management (RBM) model.
  • Bachelor’s Degree, or an equivalent combination of experience and education
  • Experienced in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within assigned geographies
  • Demonstrated ability to establish credibility internally and externally by commanding knowledge of informed consent requirements
  • Experience working with investigational review boards
  • Experience working with clinical trial management systems (e.g. Siebel CTMS, Veeva) and clinical document control systems / eTMF
  • 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, email, and in person
  • This will be a remote position and covering the UK
  • This position will be split between lead and site monitoring activities



Sounds like you? Apply submitting a cover letter and resume.



We, Boston Scientific, are an equal employment opportunity employer. We do not and will not make any personnel decisions (like recruiting, hiring, job assignments, and promotions) based on a person’s age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.




Requisition ID: 517101


As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.


So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Job Segment: Clinic, Medical, Research Associate, Medical Research, Clinical Research, Healthcare, Research

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