Senior CRA- Trial Start-Up Jobs San Diego
Responsible for clinical activities related to clinical trials and performing or managing daily in-house and outsourced operations associated with these trials.
Responsible for regulatory document procedures for study start up activities; including site identification, feasibilities, review and approval, ICF customization and approval, EC and RA submissions, as well as preparation and negotiation of Clinical Site Agreements (CSAs) at a site level.
May perform site qualification and initiation visits. Liaises with CROs, Core Labs, and other collaborators to ensure compliance with the Investigational Plan and appropriate regulations, guidelines, and policies.
Reviews data listings and tables. Educate internal/external data management on the clinical context of these documents and provide oversight of data reconciliation.
Evaluates clinical data/information. May write, and revise annual, interim, and final reports and clinical sections of regulatory submissions.
Requirements
Minimum BS in biology or healthcare required.
At least 3 years experience as an in-house CRA in pharmaceuticals.
Must have study start-up experience
Experience with international/global studies would be advantageous.
Strong knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials
Ability to travel up to 30% - 40%, within the US. Some international travel possible.
Clinical Research Associate or Monitor