Senior In-house CRA (LATAM)
About the role
Senior In-house CRA (LATAM)
We're expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we're looking for an experienced Senior In-house CRA to help build the foundation of this new regional function in LATAM!
The Senior 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 requirements (e.g., International Council for Harmonisation (ICH) -Good Clinical Practice (GCP), and country/region-specific regulations). Acting as a point of contact for study sites.
The Senior In-house CRA has broad experience and typically handles complex and advanced assignments. Individual is expected to work independently in providing support to CRA and sites. Senior In-house CRA can have increased focus on training and development of junior staff members and can act as Lead In-house CRA.
Essential Functions
- Assists 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) ensuring that sponsor and investigator obligations are being met and are compliant with ICH/GCP guidelines and applicable local regulations
- Assist with sets up 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