Senior Clinical Research Associate - FSP - Register Your Interest

## About the role Parexel FSP is beginning to actively pre recruit for 3 experienced oncology CRA's in Germany for an expected expansion of one of our key sponsors. This role is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution ## Some specifics about this advertised role - Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices. - Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met. - Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites. - Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution. - Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable ## Who are Parexel Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today's top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients. You'll be an influential member of the wider team. ## What we are looking for in this role For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart. ## Here are a few requirements specific to this advertised role - Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent - Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations - Monitoring Experience: Minimum 3.5 years relevant experience in clinical research site monitoring (preferably in Oncology) ## Responsibilities - Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices. - Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met. - Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites. - Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution. - Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable ## Requirements - Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent - Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations - Monitoring Experience: Minimum 3.5 years relevant experience in clinical research site monitoring (preferably in Oncology) ## Nice to Have ## Benefits Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today's top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients. You'll be an influential member of the wider team.