Senior Clinical Research Associate, APAC

Purpose Statement:

Monitors progress of clinical studies at the site level to 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. 

The role of Senior Clinical Research Associate as a Lead Monitor is responsible for the compliance and oversight of clinical trials that implement a Risk-Based Monitoring (RBM) strategy and being the main point of contact between the study team and site monitors. The role includes performing study compliance oversight by conducting Site Compliance Meetings, analyzing data to identify potential compliance outliers, and working with study teams and sites to resolve identified issues. The lead monitor may also provide Site Management input to the study team throughout all study phases, including study design, start‑up, enrollment, follow‑up, and close‑out.

Key Responsibilities:

• Develop and execute monitoring plans through protocol analysis for remote risk management. Continually monitor data and analyze findings to decide whether to conduct a remote or targeted on-site monitoring visit.
• Prepare for and conduct regular Site Compliance Meetings, reviewing Key Risk Indicator and any associated action items. Oversee monitors and ensure adherence to service level agreements as well as legal and regulatory standards.
• Collaboration: participates in study-specific meetings, teleconferences and trainings. Conduct regular meetings with monitor team. Collaborates with cross-functional team members and study sites throughout all study phases. Collaborate with clinical KOLs and internal teams to manage clinical strategy and support audit response.
• 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.
• 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.

Requirements:

• Bachelor’s degree or equivalent required, preferably in life sciences, medicine, or a related discipline.
• Requires at least 5 years of site management experience or equivalent experience in clinical research, with an understanding of clinical trial methodology and terminology.
• In‑depth knowledge of, and skill in applying, applicable clinical research regulatory requirements (e.g., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and ISO 14155).
• Strong interpersonal, verbal, and written communication skills, including good command of the English language.
• Expertise in site management and data integrity, with proficiency in relevant clinical trial software and tools.
• Ability to establish and maintain effective working relationships with cross‑functional teams and stakeholders. Able to initiate and maintain work schedules and priorities
• Strong organizational and problem‑solving skills. Able to independently determine and develop approaches to solutions. Assists in establishing departmental policies and procedures
• Ability to work across cultures and to mentor less experienced staff by setting an example, providing guidance, and offering counsel.
• Able to accommodate extensive travel requirements according to task allocation and the status of assigned studies.

Requisition ID: 621283

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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!