Clinical Research Associate - P4

Position : Sr. Clinical Research Associate
Work Mode : Remote in Country
Requisition ID : 8300684
Additional Location(s): Taiwan

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:
This position will cover site management and role of lead monitor in study team.
- As role of CRA : Monitor progress of clinical studies at the site level to verify that the rights and wellbeing 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.
- As role of Lead MCRA : Integrates the centralized monitoring of clinical data recommended by global regulations into a role that is the primary centralized contact for identified studies.

Your Responsibilities will Include:
• Team Leadership: LMCRA s will have the primary responsibility for all Site Management deliverables and be the primary point of contact for the study team. Lead and mentor study monitoring team for site management.
• Study Planning and Risk Management : LMCRA will work in conjunction with the CTM/CPM and the SME to involve in the development of study RACT, Monitoring plan and Risk management plan from a site management point of view. Monitoring visit compliance, support and answer MCRA questions, handle issue escalation and facilitate study compliance meetings.
• 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 acti
• 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.
Required Qualifications:
• Bachelor’s degree in Life Sciences, Nursing, or a related field with 5+ years of experience in clinical research monitoring or related roles.
• Strong understanding of GCP, ISO, and other applicable regulatory requirements.
• Proven ability to perform source verification and ensure data accuracy and completeness.
• Ability to travel approximately 50% of the time.
Preferred Qualifications:
• Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Experience in medical device clinical trial
• Certification in Clinical Research (e.g., CCRP, CCRA) or equivalent.
• Excellent written and verbal communication skills, with experience in report writing.
• Experience managing multiple projects or studies simultaneously, demonstrating strong organizational skills.

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