Clinical Research Associate II-FSP (All Location)

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 centres 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.