Clinical Research Associate II (FSP)-Cell therapy

Parexel Clinical Development Solution

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

• 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