Lead Clinical Research Associate

This is a fully remote position, open to applicants in Malaysia.

📋 Description

• Supervise and direct the clinical team while managing trial activities at a national or regional level

• Ensure execution is of high quality, compliant, and delivered on time

• Facilitate coordination among cross-functional teams

• Track project timelines, patient enrollment, data integrity, and compliance

• Implement corrective and preventive actions as necessary

• Review monitoring visit reports to ensure compliance with reporting standards

• Serve as the primary communication link among Monitors, Site Management Associates, Regional Project Leads, and Project Managers

• Conduct country-level project team meetings and provide updates and reports

• Deliver project-specific training and create training materials

• Oversee source data verification and address site-level data inquiries

• Evaluate and manage site-level study risks

• Ensure appropriate handling, accountability, reconciliation, and return of investigational products and clinical study supplies

• Review essential study documents and supervise the reconciliation of ISF/TMF

• Maintain data integrity and ensure compliance at the site level

• Collaborate on investigator/site feasibility, identification, and study initiation

• Manage Monitors in resolving queries, including Central Monitoring observations

• Coordinate the flow of safety information and reporting of protocol/process deviations

• Manage clinical supplies with vendors at national and regional levels

• Keep study-specific and corporate tracking systems updated

• Coordinate and carry out supervised monitoring visits

• Handle site contracting and payments

• Conduct audit preparation visits, participate in site audits, and oversee the resolution of audit findings

• Supervise the development and implementation of CAPA

• Manage and report on process deviation reviews

• Conduct initial training and authorization monitoring visits for Monitors

• Mentor newly promoted Lead CRAs

• Present training and information at Investigator Meetings

• Ensure subject recruitment goals and project timelines are established, communicated, documented, and achieved

• Facilitate timely information exchange with trial sites regarding adverse events and protocol/process deviations

• Oversee Site Management Associates in the flow of documents and laboratory supplies

• Assist in preparing regulatory and ethics committee submission packages

⛳️ Requirements

• Relevant educational qualifications, such as MD, MPharm, RN, or a College/University degree in Life Sciences, or a similar combination of education, training, and experience

• At least 4 years of site monitoring experience with involvement in global clinical projects as a Lead Monitor or in a similar role

• Experience with all types of monitoring visits in Phase II and/or III

• Preferred experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or rare disease indications

• Full working proficiency in English

• Competence in MS Office applications

• Ability to plan, multitask, and thrive in a dynamic team environment

• Strong communication, collaboration, and problem-solving skills

• Willingness to travel

🏝️ Benefits

• Stable and secure workplace

• Inclusive culture and welcoming environment

• Opportunities for career advancement

• Chance to coordinate diverse tasks and gain new skills

• Opportunity for growth within the company