When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Monitoring and Management of Investigator Sites
Conducts source data verification (SDV) and ensure clinical trials data are submitted to data management in a timely fashionIdentifies issues that may impact on the conduct of the study and ensure appropriate closure of all issuesProactively manages a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are metEnsures studies are run in line with ICH/GCP, local laws and Client Standard Operating Procedures (SOPs) and proceduresEnsures patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirementsInforms the Principal Investigator (PI) and site staff of all issuesAgrees and develops corrective and preventative actions with PI and site personnel to close all open issuesResponsible for all aspects of site management from collaboration on site selection to study closeoutTrains site staff on the protocol, protocol amendments and Client processesUnderstands the product, the protocol, and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator teamInteracts with health care professionals in a manner, which enhances Client’s credibility with the customerData Quality
Ensures that data monitored meets target quality standardsEnsures that data is entered into Client systems in a timely mannerReporting
Reports on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurredEnsures all issues are correctly identified and cataloguedProactively manages issues to appropriate closureMaintains accurate site-level information on corporate clinical trials registryDocumentation
Obtains critical information to enable generation of Investigator Initiation Package (IIP) documentationAssists Clinical Trial Assistant (CTA) in gathering IIP documentation where required to ensure timely site set upMaintains the Site Master File (SMF) and SMF logEnsures Electronic Library and Records Archive (ELARA) and/or Client Trial Master File (TMF) is complete and accurateQC relevant documents in ELARA and/or TMF in a timely mannerGenerates site monitoring reportsMaintains all appropriate monitoring logsCompliance with Parexel standards
Complies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes, ICH- GCPs and other applicable requirementsSkills:
Computer Literacy (word processing and spreadsheets, PowerPoint)Proficient in Chinese, good command of written and spoken English is requiredGood interpersonal skills, good at communicationA flexible attitude with respect to work assignments and new learning, quickly-learningAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailWillingness to work in a matrix environment and to value the importance of teamworkKnowledge and Experience:
At least 1.5 years (2 years preferable) of Clinical Monitoring/ Site Management experience, global study monitoring experience is preferredGood knowledge of ICH/GCP, relevant international and local regulations relating to Clinical ResearchEducation:
Degree in Life Science, Nursing, Pharmacy, or other relevant education backgroundBachelor’s degree or above, or equivalent