Principal In-house CRA (San Pedro)

Principal In-house CRA (San Pedro)

29 ago
|
Precision For Medicine
|
San Pedro

29 ago

Precision For Medicine

San Pedro

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 requirements (e.g., International Council for Harmonisation (ICH) -Good Clinical Practice (GCP), and country/region-specific regulations). Acting as point of contact for study sites.
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. Acting as resource for Clinical Monitoring management team support and mentoring and developing others in the team.
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.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

📌 Principal In-house CRA (San Pedro)
🏢 Precision For Medicine
📍 San Pedro

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