CRA
Responsibilities:
. Be responsible for clinical trial monitoring activities, ensuring all trials are conducted strictly in compliance with the clinical trial protocol, Standard Operating Procedures (SOPs)/internal operating procedures, and relevant national regulations.
. Assist the Project Manager in managing Contract Research Organizations (CROs); conduct comprehensive quality control and management for assigned research projects; complete the comprehensive initiation, execution, and site closure activities for clinical trials in China on time; communicate and coordinate efficiently and timely with personnel from other departments related to the project.
. Collaborate with other functional departments and vendors to implement patient recruitment strategies and contingency plans.
. Be responsible for timely communication with line manager regarding site selection, investigator selection, and trial budget development.
. Assist in completing relevant reports and trial documentation, ensuring the accuracy, validity, and completeness of data collected at the trial site; ensure all Adverse Events (AEs) / Serious Adverse Events (SAEs)/product quality complaints are reported within the specified timelines and properly documented. For AEs/SAEs, ensure consistency with all collected data and information in the source documents.
. Be responsible for providing feedback on issues identified during monitoring, ensuring investigators complete data entry and query resolution within the expected timeframe.
. Work closely with CROs to ensure quality issues identified during routine monitoring visits, QA audit visits, and other types of visits are resolved, and ensure the completion of relevant Corrective and Preventive Actions (CAPA).
. Be responsible for the management of project-related documents, supplies, and investigational product; communicate timely with the Project Manager regarding safety, supplies, timelines, and financial budget matters.
. Act as an external representative of the company and client, conveying important information from the company and client to investigators in a timely manner; develop and maintain good relationships with investigators; be skilled in coordinating relationships and resolving conflicts between various projects.
. Review the completeness of study files, ensuring document storage requirements are met, including secure storage at all times; review and sign all routine visit reports and other Trial Master File (TMF) documents for assigned projects.
Requirements:
. Bachelor's degree or higher in Clinical Medicine, Pharmacy, or a related field. Educational requirements may be relaxed for candidates with systematic professional training.
. Minimum 3 years of clinical monitoring experience with oncology drugs. Familiarity with Phase I clinical trial workflows is preferred.
. Ability to identify various issues during the drug clinical trial process; rigorous and standardized drug clinical trial monitoring and facilitation skills.
. Excellent communication and coordination skills, with the ability to effectively communicate with investigators, CROs, laboratories, and vendors.
. Meticulous, responsible, patient, capable of carefully reviewing relevant materials, and possess certain writing skills.
