In-House CRA II (Mexico)
About the role
In-House CRA II (Mexico)
We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile and Peru, and we’re looking for an experienced In-house CRA II to help build the foundation of this new regional function in LATAM!
The In-house CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. You will adhere to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH), Good Clinical Practice (GCP), and country/region-specific regulations). Acts as point of contact for study sites.
The In-house CRA ll is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.
Essential Functions
- Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites
- May assist in identifying study sites by performing site feasibility and recruitment tasks, e.g., 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) under general supervision ensuring that sponsor and investigator obligations are being met and are compliant with ICH/GCP guidelines and applicable local regulations
- Assist with set ups and maintains site-related data in applicable clinical systems according to procedures and guidelines Utilizes the Clinical Trial Management System (CTMS) to ensure milestones and activities are accurately tracked
- Acts as site contact/liaison for study and site management issues including addressing questions, assists with managing study supplies, and may support offsite central monitoring activities. Escalates issues and risks as needed