Clinical Research Associate II (FSP)- Hefei/Nanjing at Parexel

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

07 Aug, 26

Salary

0.0

Posted On

09 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Site Monitoring, ICH-GCP, Source Data Verification, Clinical Dataflow, Drug Development Processes, English Proficiency, Interpersonal Skills, Collaboration, Microsoft Office, Regulatory Compliance

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: Study Team Supporting Drive study performance at the sites. Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents. Provide the required monitoring visit reports within required timelines. Proactively identify study-related issues and escalates to Local Study Teams as appropriate. Contribute to the selection of potential sites and investigators. Train, support and advise Investigators and site staff in study related matters. Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations. Manage study supplies, drug supplies and drug accountability at study sites. Perform source data verification according to SDV plan. Ensure data query resolution. Work with data management to ensure quality of the study data. Ensure accurate and timely reporting of Serious Adverse Events. Share relevant information on patient recruitment and study site progress within local Study Team. Update VCV and other systems with data from centers as per required timelines. Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA. Adherence to AstraZeneca’s Code of Conduct and company policies and procedures. Compliance with Parexel standards Comply with required training curriculum. Complete timesheets accurately as required. Submit expense reports as required. Update CV as required. Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements. Skills: Understanding of the clinical dataflow. Good knowledge of the clinical study and drug development processes, GCP/ICH guidelines and relevant local regulations. Good computer skills in Microsoft and other software. Fluent in both oral and written English Proficient written and verbal communication skills, collaboration and interpersonal skills. Knowledge and Experience: Minimum 2-year experience as CRA, performed all tasks for a CRA position Read, write, and speak fluent English; fluent in host country language required. Education: Bachelor’s degree in biological science or healthcare-related field., 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 performing site monitoring and onsite visit activities to drive study performance in compliance with procedural documents. Key duties include managing study supplies, ensuring data query resolution, and reporting serious adverse events.