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.