Clinical Research Associate II Job Description
We are seeking a highly motivated Clinical Research Associate II to partner with investigator sites and ensure the proper conduct of clinical trials.
* Manage operational aspects for implementation of clinical trial activities at assigned investigator sites.
* Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
* Provide protocol training to site personnel and address protocol-related questions from investigator site staff.
Responsibilities:
* Clinical Trial Monitoring: Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
* Manage operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock.
* Partner with SCP to perform investigator site development, coaching, and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients.
* Monitor site-level AEs and SAEs and collaborate with the Drug Safety Unit to bring SAE reports to resolution.
* Submit all required reports, documentation, updates, and tracking within required timeframes.
Required Skills and Qualifications:
* Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent.
* At least 2 years of relevant experience in clinical research site monitoring and management.
* Global clinical trial experience is mandatory.
* Must be fluent in English and in the native language(s) of the country they will work in.