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 of the job included but not limited to: Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sitesMay assist in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating, and reviewing responses to site recruitment questionnairesSchedules internal and external meetings as requiredPrepares Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if requiredPerforms 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 regulationsAssist 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 trackedActs 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 neededEnsures timely and complete data entry by site in EDC or any other system that requires data entrySends email blasts/newsletter, updates,



and updated study core documents to study site personnelAssists in providing logistics support in samples management and tracking, where applicable and in study supply managementSupports investigators and investigative staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirementsAssists in data review inclusive of site level data review, resolutions provided by sites to queries, facilitates database closure and freezing procedures as per study plansAssist with study tracking via the CTMS, Study specific trackers or sponsor designated system to ensure that the study reporting is current, accurate and completeDocuments site and Sponsor contact and study interactions in a timely and professional mannerAssist in remote review of the electronical Investigator Site File, where applicableAssists with Investigational Product accountability, where applicableConsults with project team members regarding study site issuesProvides quality review of the amended site level informed consent templateFollows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator PaymentsMay attend site visits as needed, supporting the CRA to ensure sponsor and investigator obligations related to the study documentation are being met and are compliant with applicable regulatory requirements and guidelinesMay serve as an Independent Essential Document Reviewer post-SIVSupports on-site visits activities if neededMay mentor an In-house CRA Trainee (New Graduate Level)Performs other duties as assigned by managementPerforms all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements Qualifications: Minimum Required:Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business,



scientific or healthcare disciplineMinimum of 2 years of relevant experience Other required:High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)Customer service demeanor; demonstrate flexibility and teamworkAbility to focus on detail for extended periods of time, high attention to accuracyFluency in English communication, verbally and in writingWorking knowledge of the drug development processAbility to travel as needed Preferred:Solid experience in clinical research or related experienceExcellent organizational skillsAbility to work efficiently in a remote work environment Competencies:Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidanceDemonstrates solid interpersonal skillsExhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environmentGood written and verbal communication skills and presentation skillsAbility to deliver on commitmentsCommitment to performing professionally consistent with Precision Principles#LI-AG2 #LI-REMOTEAny data provided as a part of this application will be stored in accordance with our Privacy Policy.
For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer.
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📌 In-House Cra Ii (Mexico) (Xico)
🏢 Precision For Medicine
📍 Xico