Clinical Research Associate - III

Additional Locations:

Costa Rica-Heredia

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Boston Scientific's hybrid workplace includes Working From Home and onsite. You will have the opportunity to discuss details in the interview.

Primary focus is providing clinical support for the Global Clinical Operations site management team. Works under limited supervision with general instructions given on new assignments. Ensure protocols are conducted in accordance with standard operating procedures, ISO/GCP and other applicable regulatory requirements.

Perform tasks associated with the lead monitor role. Act as the primary point of contact between the Study Core Team and the monitoring team to support alignment, communication, and issue resolution.

• Facilitate communication of monitoring updates, site-level risks, action items, and escalation items between the Study Core Team and monitoring team.
• Coordinate follow-up on monitoring-related questions, documentation needs, and study-specific guidance to support consistent execution across sites.
• Support alignment of monitoring activities with study priorities, timelines, and operational expectations.

Support clinical studies internally & externally in start-up, enrollment, follow-up and closure of clinical trial activities.

Works under supervision with general instructions given on assignments.

• Likely to perform tasks associated with the lead monitor role. Tasks may include but not limited to the following:
  Site Management representative on study core team, Liaison between Study core team and the monitoring team, Provide training and support for the monitoring team throughout the study, Manage communications and team activity from a Site Management perspective;
  Manages Study compliance;
  Support audits – internal & external.
• Schedule remote visits as appropriate; such as qualification, initiation, monitoring and close out visits.
• 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.
• Manages work in a confidential manner, ensuring information is shared with internal and external individuals as appropriate.
• Provides guidance to peers as necessary regarding proprietary information.
• Documentation:
  Manages request/collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of…