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 teamMay 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) ensuring that sponsor and investigator obligations are being met and are compliant with ICH/GCP guidelines and applicable local regulationsAssist 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 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, or if needed, conducts 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 visit activities if neededProvides team leadership, training, and assessment/ coaching feedback to in-house CRA team membersLeads multiple in-house CRAs on a project, providing training and mentoring as requiredAssists management with the development of training materialsAssists project team with the development of study specific documents and proceduresMay support manager and interface with partner departments to support enhanced project deliveryParticipates in the creation and maintenance of clinical project documents including, but not limited to Clinical Monitoring Plans, Monitoring Visit Letter templates and Site Start-up Plans consulting with the CTM/SULMay act or directly assist functional team lead in supporting sponsors (may have direct client interaction) clinical budget management, vendor support/management and evaluation of metrics to identify process improvementsMay create and execute risk management strategies for their aspect of project delivery with oversight from functional team leads/functional managersPerforms 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 discipline6 years of clinical trial or related 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 writingIn-depth knowledge of the drug development processExperienced with utilizing CTMS, TMF, and EDC systemsAbility to travel as needed Preferred:Extensive experience in clinical research or related experienceExcellent communication and organizational skills are essentialAbility to work remotelySkilled in solving higher level complex problems using knowledge/skills, precedents, and practicesCan support junior In-House CRA on issues identification and resolution Competencies:In - depth knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidanceDemonstrates strong interpersonal skills and time management skillsExhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environmentExcellent written and verbal communication skills and presentation skillsAbility to deliver on commitmentsAdvanced critical thinking skillsGood leadership skillsCommitment 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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📌 Principal In-House Cra (Latam) (Xico)
🏢 Precision For Medicine
📍 Xico