Clinical Research Associate II

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

📋 Description

• Manages all facets of study site operations to ensure the protection of patient safety, high quality of data from managed sites, resulting in consistently low query levels and acceptable Quality Assurance reports.

• Offers guidance at both the site and project levels to meet audit readiness standards and aids in the preparation for audits as well as required follow-up actions.

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

• If necessary, oversees site startup processes, which include assessing feasibility and recruiting potential investigators, preparing EC/IRB submissions, collecting and reviewing regulatory documents, revising Patient Informed Consents, notifying IRB, EC, and regulatory bodies as needed, translating study-related documentation, organizing meetings, and performing other tasks as directed by the Clinical Trial Manager/Project Manager.

• If necessary, aids in the negotiation of study budgets and the execution of investigator contracts under the guidance of the Site Contract Management department or designee.

• Ensures that the informed consent process has been adequately performed and documented for each subject/patient, as required. Evaluates factors that may impact subject/patient safety and the integrity of clinical data at the investigator/physician site, such as protocol deviations/violations and pharmacovigilance issues.

• Independently conducts all types of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in compliance with the protocol, local laws, ICH-GCP, and Precision SOPs. Prepares and submits accurate and timely monitoring reports from 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 documents as per SOPs, Clinical Monitoring Plan/Site Management Plan, and client requirements. Supports subject/patient recruitment, retention, and awareness strategies. Inputs data into tracking systems as needed to monitor all observations, ongoing status, and assigned action items until resolution.

• Regularly examines 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 is informed about the requirements for archiving essential documents in accordance with local guidelines and regulations.

• Communicates effectively and proactively with site personnel and Precision Project and Clinical Trial Management to address 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 promote Precision's high-quality and professional image.

• Conducts investigational product (IP) inventory, reconciliation, and reviews storage and security. Confirms that the IP has been dispensed and administered to subjects/patients per the protocol. Assesses issues or risks associated with blinded or randomized information relating to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure the IP is appropriately (re)labeled, imported, and released/returned.

• Engages in data review activities, including remote EDC CRF and patient profiles review, query resolution, and collaborates with data management and clinical data quality personnel to resolve data discrepancies.

• Identifies and processes Serious Adverse Events following the procedures established by the study team. Demonstrates 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 support from the project team.

• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (including Sponsor representation, as applicable) and attends clinical training sessions based on project-specific requirements.

⛳️ Requirements

• Bachelor's degree / international equivalent or a suitable combination of education and experience, ideally in a business, scientific, or healthcare discipline.

• At least 2 years of on-site monitoring experience; 1 year in oncology.

• Experience in Global Clinical Trials.

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

• Strong customer service orientation; displays flexibility and teamwork.

• Ability to maintain focus on details for extended periods, demonstrating high accuracy.

• Excellent proficiency in English communication, both verbally and in writing.

• Understanding of the drug development process.

• Willingness to travel (60-70%).

• Significant experience in clinical research or a related field.

• Outstanding organizational skills.

• Ability to work effectively in a remote work environment.

🏝️ Benefits

• Travel as necessary based on project requirements.

• Performs additional duties as assigned by management.