Parexel FSP is inviting applications for the role of Clinical Research Associate (CRA) or Senior Clinical Research Associate (Sr CRA). If you have a background in Oncology and experience with Cell Therapy, this could be the perfect opportunity for you.

Job Purpose: As a CRA, you will oversee the execution of clinical studies at designated sites, working closely with the local study team to ensure that study commitments are met efficiently. You will serve as the primary contact for study sites, monitoring study conduct and ensuring adherence to regulatory requirements and client standards.

Key Responsibilities:
• Participate in investigator selection and site initiation, ensuring compliance with local regulations and guidance.
• Train and support investigators and site staff on study processes, including Risk Based Quality Management principles.
• Conduct monitoring visits (both remote and onsite) to ensure data integrity, compliance, and site readiness for inspections.
• Maintain accurate records and data integrity within the Clinical Trial Management Systems (CTMS).
• Identify and resolve any study-related issues proactively, escalating as needed.
• Monitor study supplies and manage drug accountability at study sites.
• Collaborate in local study team meetings and contribute to site performance discussions.
• Ensure timely reporting of Serious Adverse Events and maintain study documentation in compliance with ICH GCP and local requirements.
• Prepare for regulatory audits and inspections, ensuring all essential documents are readily accessible.

Essential Skills:
• Strong attention to detail and excellent verbal/written communication skills.
• Good collaboration, negotiation, and interpersonal abilities.
• Proficiency in English and fluency in local languages.

Desirable Skills:
• Ability to manage change positively and seek efficient methods of conducting clinical trials.
• Strong analytical and problem-solving skills.
• Capability to handle multiple tasks with competing deadlines.
• Team-oriented mindset with flexibility in adapting to shifting demands.

Knowledge and Experience:
• Solid knowledge of ICH GCP guidelines along with basic understanding of GMP/GDP.
• A comprehensive grasp of clinical study management and drug development processes.

Education:

Bachelor's degree in a related field, preferably in life sciences, or an equivalent qualification that supports the required skills for this role.

Additional Requirements:
• Ability to travel nationally and internationally as required.
• Valid driver's license as per country regulations.

EEO Disclaimer: Parexel is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.