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Senior Monitor / Site Management Clinical Research Associate
This role can be remote and can sit anywhere in the Western US, based on BSC Clinical and functional experience.
About this role:
This responsible for clinical research field monitoring and project team clinical research support throughout the full lifecycle of a clinical project. Support of projects of a more complex nature and mentoring and training of junior level staff.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.
This individual will support the western US
Your responsibilities include:
Role: Site Manager
- Ensures monitoring, monitoring report review/finalization, event reporting and all other monitoring commitments are performed in accordance with the study monitoring plan.
- Manages assigned clinical sites, partnering with field monitors and site staff to identify and escalate or resolve compliance issues, and escalation of site questions or needs.
- Participates in site start up activities as assigned.
- Routinely reviews site compliance data and works to identify compliance risks and issues.
- Partners with field staff to develop a CAP to address non-compliance issues as appropriate.
- Manages the completion of assigned project specific deliverables.
- Participate in site close-out activities for assigned clinical sites.
- Partners with colleagues to ensure assigned sites are audit ready at all times.
- Conducts a thorough comparison (monitor) of case report forms against medical records on complex trials at multiple sites.
- Addresses non-compliance issues and trends at investigative site; develops, documents, and implements a CAP as necessary.
- Conducts qualifications, initiation, interim and close out visits. Ensures all appropriate site staff are trained, have access to required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements.
- Participates as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences, and investigator meetings.
- Conducts device accountability at clinical sites.
- Conducts study specific training for new study coordinators.
- Ensures that all adverse events are identified and clearly documented during visits.
- Serves as a mentor and trainer of junior Field CRA staff.
Role: Quality and Process Improvement Champion
- Identifies and Reports complaints.
- Identifies and ensures communication of the need for corrective action at clinical sites. Collaborates with colleagues and clinical sites to develop and execute corrective action plans.
- Ensures training is completed per the required timelines and project needs.
- Identifies process improvement opportunities. Independently proposes solutions/plans.
- Tracks internal process metrics data to measure performance.
What we’re looking for:
- Bachelor’s degree and/or equivalent combination of education and experience
- 5+ years of clinical research experience or monitoring experience, ideally medical device experience, knowledge of applicable clinical research regulations (FDA, GCP, ISO)
- Must be able to travel 50-75%’
- Strong communication and organizational skills required
- Experience monitoring cardiology studies
Requisition ID: 495439
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!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.