Senior CRA - SSU Focus - FSP
WFA Digital Insight
The demand for skilled clinical research professionals has surged in recent years, with a 25% increase in job postings for remote CRA roles. As the pharmaceutical industry continues to shift towards decentralized trials, companies like Parexel are at the forefront of this change. With a strong focus on oncology trials, this Senior CRA role offers a unique opportunity to work on high-impact studies. Candidates should be prepared to showcase their expertise in SSU activities, as well as their ability to work independently in a remote setting.
Job Description
About the Role
As a Senior CRA at Parexel, you will play a critical role in the development and execution of clinical trials. Your primary focus will be on SSU activities, including site qualification visits, study start-up, and site management. You will work closely with the site team, sponsors, and other stakeholders to ensure the successful initiation and conduct of clinical trials.The role entails a high level of autonomy, with the expectation of managing multiple studies simultaneously. You will be responsible for developing and implementing study plans, customizing plans with site teams, and ensuring compliance with regulatory requirements.
Parexel is a leading provider of clinical research services, with a strong reputation for delivering high-quality results. As a Senior CRA, you will be part of a dynamic team that is committed to improving the world's health through innovative and effective clinical trials.
What You Will Do
- Conduct Site Qualification Visits (on-site or remote) to assess site suitability for clinical trials
- Develop and implement study plans, including site recruitment plans and source data agreements
- Customize plans with site teams to ensure effective study start-up and conduct
- Ensure compliance with regulatory requirements, including GCP and ICH guidelines
- Manage multiple studies simultaneously, prioritizing tasks and deadlines to meet project timelines
- Collaborate with sponsors, site teams, and other stakeholders to ensure successful trial execution
- Upload time-critical documents to eTMF and maintain accurate study records
- Participate in local study team and set-up team meetings to discuss study progress and issues
- Train, support, and advise Investigators and site staff on study-related assessments
What We Are Looking For
- Minimum of 3 years' experience in independent monitoring, with a focus on SSU activities
- In-depth experience of performing SSU activities, including site qualification visits and study start-up
- Oncology trial experience is essential, with a strong understanding of the clinical and regulatory aspects of oncology trials
- BSc in life sciences is preferred, with a strong foundation in biology, chemistry, or a related field
- Excellent communication and interpersonal skills, with the ability to work effectively with site teams, sponsors, and other stakeholders
- Strong organizational and time management skills, with the ability to prioritize tasks and manage multiple studies simultaneously
Nice to Have
- Experience with CTMS and eTMF systems
- Knowledge of regulatory requirements, including GCP and ICH guidelines
- Familiarity with clinical trial protocols and study designs
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work on high-impact clinical trials, with a focus on oncology and other therapeutic areas
- Collaborative and dynamic work environment, with a team of experienced clinical research professionals
- Professional development opportunities, including training and education programs
- Flexible working arrangements, including remote work options
- Access to cutting-edge technology and tools, including CTMS and eTMF systems
How to Stand Out
- Showcase your experience with SSU activities, including site qualification visits and study start-up
- Highlight your knowledge of regulatory requirements, including GCP and ICH guidelines
- Be prepared to discuss your experience with clinical trial protocols and study designs
- Emphasize your ability to work independently in a remote setting, with strong organizational and time management skills
- Consider creating a portfolio of your work, including examples of study plans and site management documents
- Research Parexel's company culture and values, and be prepared to discuss how your skills and experience align with their mission
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