Senior Clinical Research Associate

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

📋 Description

• Provide comprehensive assistance to clinical project teams and study sites involved in clinical research studies.

• Comply with protocols, standard operating procedures (SOPs), ICH-GCP, GPP, and relevant country/region-specific regulations.

• Serve as the primary contact for study sites and independently execute key responsibilities across multiple studies.

• Supervise study site management to safeguard patient safety and ensure the integrity of data quality.

• Guide sites and projects towards audit readiness while supporting audit preparation and follow-up activities.

• Maintain trial management tools, systems, and status reports specific to each study.

• When necessary, manage site start-up activities, including feasibility assessments, investigator recruitment, EC/IRB submissions, regulatory documents, informed consents, notifications, translations, and meetings.

• Assist with negotiations regarding study budgets and investigator contracts as required.

• Validate informed-consent processes and documentation; evaluate safety, protocol deviations, violations, and pharmacovigilance matters.

• Conduct pre-study/qualification, initiation, routine monitoring, and close-out visits independently, both on-site and remotely.

• Generate timely monitoring reports and document activities through necessary project documents and tracking systems.

• Support strategies for subject/patient recruitment, retention, and awareness.

• Review and reconcile Investigator Site Files with Trial Master Files and ensure proper archiving of essential documents.

• Proactively communicate study issues with site personnel and Precision project and clinical trial management teams.

• Maintain relationships with investigators and study staff, representing Precision’s commitment to quality and professionalism.

• Manage the inventory, reconciliation, storage, security, dispensing, administration, labeling, import, and return/release of investigational products.

• Conduct remote EDC CRF and patient-profile reviews, addressing queries and assisting with data discrepancies.

• Identify and process Serious Adverse Events in accordance with study procedures.

• Recognize site risks, escalate them with suggested contingencies, and ensure timely resolution.

• Attend Investigator Meetings, sponsor meetings, global monitoring/project meetings, and necessary clinical training.

• Travel as required based on project needs.

• Carry out additional duties as assigned by management.

⛳️ Requirements

• Bachelor's degree or international equivalent, or a combination of education and experience, preferably in a business, scientific, or healthcare field.

• At least 2 years of on-site monitoring experience.

• Minimum of 1 year of experience in oncology.

• Experience with global clinical trials.

• High proficiency in Microsoft Office, including Outlook, Word, Excel, and PowerPoint.

• Strong customer service demeanor with flexibility and teamwork capabilities.

• Ability to maintain focus on details for extended periods while ensuring high accuracy.

• Proficient in English communication, both verbal and written.

• Working knowledge of the drug development process.

• Willingness to travel (60–70%).

🏝️ Benefits

• Equal Opportunity Employer

• Reasonable accommodations available for applicants with disabilities

• Application data stored in accordance with the Privacy Policy