Clinical Research Associate II at Parexel

Chengdu, Sichuan, China -

Full Time

Start Date

Immediate

Expiry Date

11 Aug, 26

Salary

0.0

Posted On

14 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Computer Literacy, Chinese Proficiency, English Proficiency, Interpersonal Skills, Communication, Task Prioritization, Teamwork, Site Management, Clinical Monitoring, Source Data Verification, ICH/GCP Compliance, Patient Safety Reporting

Industry

Pharmaceutical Manufacturing

Description

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 fashion • Identifies issues that may impact on the conduct of the study and ensure appropriate closure of all issues • Proactively manages a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met • Ensures studies are run in line with ICH/GCP, local laws and Client Standard Operating Procedures (SOPs) and procedures • Ensures patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements • Informs the Principal Investigator (PI) and site staff of all issues • Agrees and develops corrective and preventative actions with PI and site personnel to close all open issues • Responsible for all aspects of site management from collaboration on site selection to study closeout • Trains site staff on the protocol, protocol amendments and Client processes • Understands the product, the protocol, and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team • Interacts with health care professionals in a manner, which enhances Client’s credibility with the customer Data Quality • Ensures that data monitored meets target quality standards • Ensures that data is entered into Client systems in a timely manner Reporting • 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 occurred • Ensures all issues are correctly identified and catalogued • Proactively manages issues to appropriate closure • Maintains accurate site-level information on corporate clinical trials registry Documentation • Obtains critical information to enable generation of Investigator Initiation Package (IIP) documentation • Assists Clinical Trial Assistant (CTA) in gathering IIP documentation where required to ensure timely site set up • Maintains the Site Master File (SMF) and SMF log • Ensures Electronic Library and Records Archive (ELARA) and/or Client Trial Master File (TMF) is complete and accurate • QC relevant documents in ELARA and/or TMF in a timely manner • Generates site monitoring reports • Maintains all appropriate monitoring logs Compliance with Parexel standards • Complies with required training curriculum • Completes timesheets accurately as required • Submits expense reports as required • Updates CV as required • Maintains a working knowledge of and complies with Parexel processes, ICH- GCPs and other applicable requirements Skills: • Computer Literacy (word processing and spreadsheets, PowerPoint) • Proficient in Chinese, good command of written and spoken English is required • Good interpersonal skills, good at communication • A flexible attitude with respect to work assignments and new learning, quickly-learning • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail • Willingness to work in a matrix environment and to value the importance of teamwork Knowledge and Experience: • At least 1.5 years (2 years preferable) of Clinical Monitoring/ Site Management experience, global study monitoring experience is preferred • Good knowledge of ICH/GCP, relevant international and local regulations relating to Clinical Research Education: • Degree in Life Science, Nursing, Pharmacy, or other relevant education background • Bachelor’s degree or above, or equivalent Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

The role involves monitoring and managing investigator sites, conducting source data verification, and ensuring clinical trials are run in compliance with ICH/GCP and local laws. Responsibilities also include training site staff, maintaining the Site Master File, and reporting study progress to relevant personnel.