Note: The job is a remote job and is open to candidates in USA. Boston Scientific is a global medical technology leader that transforms lives through innovative medical technologies. They are seeking a Clinical Research Associate to monitor clinical studies, ensuring compliance with protocols and regulatory requirements while supporting trial activities from start to closure.
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
Skills
- University degree or the equivalent combination of education and experience required
- 1-3 years relevant experience
Benefits
- Relocation assistance is not available for this position at this time.
- Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.
- Access to the latest tools, information and training
- Will help you in advancing your skills and career
- You’ll be supported in progressing – whatever your ambitions
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