Clinical Research Associate Role Overview
We are seeking a highly skilled and experienced Clinical Research Associate to join our team. In this role, you will be responsible for overseeing all aspects of pharmaceutical site management, ensuring accurate pharmacy documentation, and maintaining investigational medicinal product (IMP) accountability.
Key Responsibilities:
* Own all aspects of pharmaceutical site management as described in the study monitoring plans
* Ensure accurate pharmacy documentation
* Maintain investigational medicinal product (IMP) accountability
* Ensure blinded and unblinded site staff members can work in a coordinated manner without compromising the blinded monitors
* Oversee that IMP supplies are maintained in suitable storage conditions and are accurately reconstituted, dispensed, administered, returned and destroyed.
* Cooperate closely with blinded CRA site leads to ensure contracts and agreements (e.g. Site Blinding Plans) are developed and signed off per the unblinded delivery requirements.
* Review Case Report Forms (CRF), generate queries and resolve issues in accordance with established data review guidelines on Covance or client data management systems
* Write trip reports after each onsite or remote visit
* Support the sites (pharmacies) with any issue / question they have concerning the IP (investigational product)
* Conduct regular eTMF (Trial Master File) updates
* Participate in regular study team calls and internal departmental meetings
Requirements
To be successful in this role, you will need to possess the following skills and qualifications: