About this role
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.
Typical Accountabilities
Drive performance at the sites. Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with AZ 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 investigators. Train, support and advise Investigators and site staff in study related matters.
Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations. Manage study supplies (ISF, CRF, etc), 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 Delivery Team Lead and QA.
Adherence to AstraZeneca’s Code of Conduct and company policies and procedures.
Education, Qualifications, Skills and Experience
Essential
Bachelor degree in biological science or healthcare-related field, or equivalent
Minimum 2-year experience as CRA or other related fields. Experience as a clinical monitor, performed all tasks for a CRA position.
Knowledge of the Monitoring Process, such as understanding of the Study Drug Handling Process and the Data Management Process, etc.
Understanding of the clinical dataflow
Solid 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.
Desirable
Proactively identifies risks and issues and possible solutions
Develops knowledge of therapy area through experience and review of scientific literature, and demonstrates ability to learn new therapy areas
Demonstrates ability to prepare and deliver study related training materials
Ability to coordinate work in a cross-functional international team environment, with certain level of influence and negotiation skills.
Analysis on the current clinical trial and site monitoring situation, able to think of the improvement areas and solutions.
Other facts
About Parexel
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 24,000+ 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.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites (SCRS) Eagle Award.
Community Guidelines
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• Referencing criminal or illegal activity.
• Spamming.
We reserve the right to remove comments that do not adhere to our guidelines and report users who violate the rules of our page.
What you'll do
- The Clinical Research Associate II is responsible for driving performance at clinical trial sites, performing site monitoring, and ensuring compliance with regulatory standards. They will also train and support investigators and site staff while managing study supplies and data quality.
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