Senior Clinical Research Associate

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

📋 Description

• Manages all facets of study site operations to guarantee patient safety, ensure the quality of data produced by managed sites, which leads to consistently low query rates and satisfactory Quality Assurance reports.

• Provides direction at both the site and project levels in alignment with audit readiness standards and aids in preparation for audits and necessary follow-up actions.

• Updates, monitors, and maintains study-specific trial management tools, systems, and status reports.

• If needed, oversees site startup processes including evaluating and recruiting potential investigators, preparing EC/IRB submissions, collecting and reviewing regulatory documents, revising Patient Informed Consents, notifying IRB, EC, and regulatory authorities as appropriate, translating study-related documentation, organizing meetings, and executing other tasks as directed by the Clinical Trial Manager/Project Manager.

• If necessary, assists in negotiating study budgets and executing investigator contracts under the guidance of the Site Contract Management department or designated representatives.

• Confirms that the informed consent process has been thoroughly conducted and documented for each subject/patient as required. Evaluates factors that could impact subject/patient safety and the integrity of clinical data at an investigator/physician site, such as protocol deviations, violations, and pharmacovigilance concerns.

• Independently conducts various site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP, and Precision SOPs. Prepares and submits accurate and timely monitoring reports for all site visits (both on-site and remote) for review.

• Records activities through confirmation letters, follow-up letters, trip reports, communication logs, and other necessary project documentation as per SOPs, Clinical Monitoring Plan/Site Management Plan, and client requirements. Supports strategies for subject/patient recruitment, retention, and awareness. Inputs data into tracking systems as needed to monitor all observations, ongoing statuses, and assigned action items until resolution.

• Regularly reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles the contents of the ISF with the Trial Master File (TMF). Ensures that the investigator/physician site understands the requirement for archiving essential documents in accordance with local guidelines and regulations.

• Effectively and proactively communicates with both site personnel and Precision Project and Clinical Trial Management to convey protocol/study issues, including any deviations, and implements necessary actions in response to those issues.

• Cultivates and maintains positive working relationships with investigators and study staff, acting as an ambassador to uphold Precision's high quality and professional image.

• Conducts investigational product (IP) inventory, reconciliation, and reviews storage and security protocols. Verifies that the IP has been dispensed and administered to subjects/patients in accordance with the protocol. Identifies issues or risks related to blinded or randomized information concerning IP. Applies knowledge of GCP/local regulations and organizational procedures to confirm that IP is appropriately (re)labelled, imported, and managed.

• Engages in data review activities, which include remote EDC CRF and patient profile reviews, query resolution, and assisting data management and clinical data quality personnel in resolving data discrepancies.

• Identifies and processes Serious Adverse Events in accordance with the procedures established by the study team, demonstrating a comprehensive understanding of the SAE reporting process.

• Recognizes site risks and escalates them to the Clinical Trial Manager/Project Manager with proposed contingencies. Takes ownership of the timely and appropriate resolution of the risk with minimal assistance from the project team.

• Prepares for and participates in Investigator Meetings and/or in-person sponsor meetings. Takes part in global clinical monitoring/project staff meetings (including Sponsor representation, as applicable) and attends clinical training sessions as dictated by project-specific requirements.

• Travels as required based on project needs.

• Performs other tasks as assigned by management.

⛳️ Requirements

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

• At least 2 years of on-site monitoring experience for CRAII; 1 year of oncology and Phase I experience is preferred.

• High proficiency in Microsoft Office applications (Outlook, Word, Excel, and PowerPoint).

• Customer service-oriented demeanor; demonstrates flexibility and teamwork.

• Strong attention to detail for extended periods, with a high level of accuracy.

• Fluent in English communication, both verbal and written.

• Working knowledge of the drug development process.

• Willingness to travel (60-70%).

🏝️ Benefits

• Health insurance

• Professional development opportunities