
Clinical Research Professional
Há 6 dias
Job Overview
Parexel FSP is currently seeking to fill the position of Senior Clinical Research Associate. This role will involve site management, monitoring and close-out of assigned clinical trials investigator sites.
The successful candidate will be responsible for ensuring patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards.
The key responsibilities of this position include:
- Managing operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock.
- Ensuring relevant timelines and quality deliverables are met.
- Providing primary point of contact for assigned investigator sites and working in partnership with Site Care Partner to ensure quality of site delivery.
- Partnering with Site Care Partner to perform investigator site development, coaching and training of site personnel.
- Conducting onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities.
- Monitoring site level adverse events (AEs) and serious adverse events (SAEs).
- Submitting all required reports, documentation, updates and tracking within required timeframes.
To be considered for this position, candidates must possess extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
A minimum of 3 years relevant experience in clinical research site monitoring is required, preferably 2 years in Oncology.
Requirements
Candidates should have a strong understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team.
This role requires a high level of autonomy and flexibility, with the ability to work independently and as part of a team.
We are an equal opportunities employer and welcome applications from diverse candidates.
About Us
We are a leading provider of clinical research services and are committed to delivering high-quality results to our clients.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
How to Apply
If you are a motivated and experienced individual looking for a new challenge, please submit your application today.
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