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.