About the position
At Parexel, the Clinical Research Associate (CRA) role transcends the typical responsibilities of a clinical monitor. CRAs are entrusted with the critical task of building and maintaining relationships with clinical sites, ensuring they are well-equipped for success. As the primary point of contact for these sites, CRAs address and resolve any issues or questions that may arise, managing site quality and delivery from the initial identification phase through to the close-out of the study. This role is supported by world-class technology and tailored training that aligns with individual experience levels. Notably, CRAs at Parexel can expect reduced travel requirements and a lighter protocol load compared to industry standards. The position offers opportunities for career advancement in clinical research, along with a bonus incentive program for hard work and dedication. If you value impact, flexibility, and professional development, Parexel could be the ideal workplace for you.
Responsibilities
- Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
- Oversee the integrity of the study and utilize problem-solving skills to foster rapport with site staff.
- Review the performance of the trial at designated sites to ensure the rights and well-being of human subjects are safeguarded in accordance with the protocol.
- Develop patient recruitment strategies in collaboration with clinical sites to meet enrollment timelines while ensuring compliance with approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and applicable regulatory requirements.
- Evaluate the quality and integrity of reported data, site efficacy, and drug accountability.
- Monitor the completeness and quality of regulatory documentation and perform site document verification.
Requirements
- 18+ months of Clinical Research Associate (CRA) monitoring experience in clinical research with a solid understanding of clinical trial methodology and terminology.
- Bachelor's or equivalent degree in biological science, pharmacy, or another health-related discipline.
- Strong interpersonal, written, and verbal communication skills within a matrixed team environment.
- Ability to work independently with a sense of urgency and minimal oversight.
- A client-focused approach with a flexible attitude towards assignments and new learning opportunities.
- Capability to manage multiple tasks, evaluate unpredictable scenarios, and meet project timelines while applying knowledge of study protocols.
- An honest and ethical work approach to support the development of life-changing treatments for patients.
- Strong computer skills, including knowledge of Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office products such as Excel and Word.
Benefits
- Bonus incentive program
- Career advancement opportunities
- World-class technology and training
- Less travel compared to industry peers
- Supportive management for career growth
