Clinical Research Associate

Job description

This role is based in Kuala Lumpur. Please note that Boston Scientific does not offer relocation support for this position. Applicants should be based in, or have valid work authorization for this location. **Purpose Statement:** The Clinical Research Associate supports 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, in partnership with the company’s divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection. **Key Responsibilities:** - **Coordinate and Lead:** Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, drive site regulatory submissions and essential document collection for clinical research sites throughout start up, enrollment, follow-up, and closure of clinical trial activities. - **Document Management:** Handle multiple sets of essential regulatory documents across several studies. - **Collaborate:** Partner with clinical sites to negotiate and customize Informed Consent Forms (ICF). Collaborate cross functionally to achieve business objectives. - **Relationship Building:** Develop and foster relationships with internal customers and clinical research sites to become a subject matter expert in site start-up regulatory processes. - **Problem Solving:** Assist clinical research sites with application submission processes and approval tracking to meet target IRB/EC timelines. Problem-solve site start-up challenges to mitigate impact on service level agreements and study goals. - **Prepare and Track:** Prepare, complete, and track required regulatory, ICF, and legal documentation. - **Quality Assurance:** Document site and investigator readiness for participation across multiple studies. - **Support:** Assist with internal quality audits and regulatory inspections. - **Maintain:** Keep study-specific startup and close-out trackers updated. - **Update:** Maintain site-specific metrics in Clinical Trial Management Systems and electronic Trial Master File (eTMF). - **Communicate:** Provide updates to leadership on site start-up activities, investigator readiness, regulatory submission, and approval status. - **Compliance:** Ensure adherence to regulatory requirements (ICH/GCP, MDR, GDPR) and internal SOPs/WI, policies, and procedures. **Requirements:** - Degree in relevant scientific/ healthcare subject or equivalent industry experience. - Minimum 2 - 3 years of relevant experience and previous experience as a Research Coordinator or Clinical Research Associate/Study Start-up Specialist. - Familiarity with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems/eTMF. - Solid communication skills and ability to interact with clinical research site personnel. - Ability to work independently and in a team environment. - Strong problem-solving skills and learning agility. Requisition ID: 634221 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!