(Sr.) Clinical Research Associate

The (Sr.) will be responsible for performing study site management activities, including, pre-study visit, site start up, site initiation, routine site monitoring and site close out, and ensuring site is managed according to Hutchmed SOPs, GCP and other relevant regulations.

MAJOR RESPONSIBILITIES AND DUTIES

Act as the main line of communication between the sponsor and clinical site Responsible for all aspects of study site management including conduct of pre-study visit, and site start up activities including site initiation visit, routine monitoring and close-out of clinical sites, maintenance of study files; liaise with vendors; and other duties, as assigned General On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to enroll qualified patient(s) into study Ensure study training is released to relevant site staff(s) before study specific activities Ensure the protection of study patient by verifying that informed consent procedures and protocol requirements are adhered to according to relevant requirements Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review Monitor data for missing or implausible data Ensure the resources of the sponsor are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines Verify that all delegated site staffs, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout Track and follow-up on serious adverse event (SAE) and SAE Reporting Track and follow-up on study site payment(s) Verify that the investigator follows the approved protocol and all GCP procedures Verify that source data/documents and other trial records are accurate, complete, and well maintained Verify adverse events, concomitant medications, and intercurrent diseases are reported in accordance with the protocol on the CRFs Update, track and maintain study-specific trial management tools/systems Generate and track investigational product shipments and study supplies, as needed Attend investigators' meetings, project team meetings and teleconferences accordingly Report the site management activities via Monitoring Visit Report, contact report or other types of reports Collect and upload essential documents into eTMF system according to relevant requirements Ensure site issue is followed up and closed in appropriate way within timeline Monitor more complex study independently, such as phase II, III study Due to the nature of this position, it may be required for the employee to travel in the efficient way and according to study specific frequency and Hutchmed travel policy Participate in training and mentoring new staff or junior CRA as required Perform other duties as assigned by management Joining partial project management activities according to assignment: Partial working time could be spent on small-scale clinical trials management activities refer to CPM’s Job Responsibilities as requested under line manager’s support, as a part of achieving personal development in the CRA position. Support PM to do the part working of project management as lead CRA

QUALIFICATIONS

Bachelor‘s degree, or above, in medicine, science or related discipline At least 3 years of experiences in site management activities as CRA role with solid site monitoring experience, also have specific knowledge in oncology therapeutic area Professional understanding of the clinical trial process and strong interest in clinical research Strong knowledge on ICH Guidelines and GCP including the knowledge of regulatory requirements Be familiar with some basic management skill, such as planning, organizing, coordinating, problem solving Be good at collaboration with internal and external stakeholders Strong willingness to drive result Be familiar to review and evaluate clinical data Good oral and written communication skills Professional use of English, both written and oral #J-18808-Ljbffr HUTCHMED