We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for an experienced Principal In-house CRA to help build the foundation of this new regional function in LATAM!The Principal In-house CRA provides overall support to study sites and clinical project teams engaged in clinical research studies.
Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory.
The Principal In-house CRA has extensive site management experience which included experience and knowledge across different type of projects.
The Principal In-house CRA is responsible for providing senior oversight and act as subject matter expert in site management activities.
Essential functions of the job included but not limited to: Performs and manages investigator recruitment activities and assists with development of tools such as phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites in partnership with study team May assist in identifying study sites by performing site feasibility and recruitment tasks, e.
, completing, disseminating, and reviewing responses to site recruitment questionnaires Schedules internal and external meetings as required Prepares Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if required Performs ongoing essential document collection and review, maintenance, and close-out activities, organizing and maintaining site level data in the trial master file (TMF) ensuring that sponsor and investigator obligations are being met and are compliant with ICH/GCP guideline.