Job summary
Job post source
This job is directly from Parexel
Job overview
The Clinical Research Associate II/Site Monitor II role at Parexel involves ensuring data integrity, quality, and compliance with clinical trial protocols and regulations, primarily for vaccine studies, impacting study success and regulatory adherence.
Responsibilities and impact
The role includes monitoring clinical trial sites virtually and onsite to ensure compliance with ICH-GCP and protocol, verifying informed consent, reviewing source documents and data accuracy, managing protocol deviations, supporting investigational product handling, and maintaining communication and documentation to meet project goals.
Experience and skills
Requires a minimum of 3 years clinical monitoring experience, familiarity with systems like Siebel CTMS, eTMF, eISF, and experience in vaccine trial monitoring; a Bachelor's degree or RN qualification is essential.
Unique job features
The position offers a hybrid monitoring approach combining virtual and onsite visits, emphasizing vaccine trial expertise and use of advanced clinical trial management systems.
Company overview
Parexel is a global biopharmaceutical services organization that provides comprehensive drug development and regulatory consulting services to the pharmaceutical, biotechnology, and medical device industries. They make money by offering clinical research, regulatory consulting, and market access services that help clients expedite the development and approval of new therapies. Founded in 1982, Parexel has a long history of innovation in clinical research and has been involved in the development of many significant medical treatments.
How to land this job
Tailor your resume to emphasize your clinical monitoring experience, especially your familiarity with vaccine trials and adherence to ICH-GCP guidelines, highlighting your ability to ensure data integrity and regulatory compliance at the site level.
Focus on showcasing your skills in remote and on-site monitoring, use of clinical trial management systems like Siebel CTMS, eTMF, and eISF, and your capacity to manage protocol deviations, query resolution, and investigational product accountability.
Apply through multiple platforms including Parexel's corporate career site and LinkedIn to maximize your application visibility and reach within the company.
Connect with current Clinical Research Associates or Site Monitors at Parexel on LinkedIn, initiating conversations by referencing recent vaccine trial advancements or asking about remote monitoring best practices as ice breakers.
Optimize your resume for ATS by incorporating keywords such as 'ICH-GCP compliance,' 'clinical monitoring,' 'vaccine trials,' 'Siebel CTMS,' 'protocol adherence,' and 'remote monitoring' to ensure it passes automated screenings effectively.
Use Jennie Johnson's Power Apply feature to automate tailoring your resume, find multiple application portals, and identify LinkedIn contacts to network with, allowing you to focus your energy on preparing for interviews and strategic follow-ups.
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