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In-House CRA II – Mexico
Precision Medicine GroupIn-house CRA II providing overall support to clinical study sites engaged in research studies. Seeking experienced professional to help build a new regional function in LATAM.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research support, including adherence to regulatory requirements and effective communication with study sites. Proficient in data management and document organization, ensuring compliance with Good Clinical Practice and other relevant guidelines.
Highest-signal resume keywords
Clinical Research SupportGood Clinical Practice (GCP)Data Entry in EDCMicrosoft Office ProficiencyFluency in English Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchData ManagementDocument ReviewSite Feasibility AssessmentInvestigator RecruitmentRegulatory ComplianceAttention to DetailData EntryStudy Site CoordinationProject Support
Soft Skills
Customer ServiceTeamworkFlexibilityProfessional CommunicationDetail-Oriented
Tools & Technologies
Electronic Data Capture (EDC)Microsoft OutlookMicrosoft WordMicrosoft ExcelMicrosoft PowerPoint
Industry Keywords
International Council for Harmonization (ICH)Drug Development ProcessStandard Operating Procedures (SOPs)Clinical Trial ManagementStudy Site Interaction
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide overall support to study sites and clinical project teams engaged in clinical research studies
- 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)
- Act as point of contact for study sites
- 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
- Schedule internal and external meetings as required
- Prepare Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if required
- Perform ongoing essential document collection and review, maintenance, and close-out activities, organizing and maintaining site level data
- Ensure timely and complete data entry by site in EDC or any other system that requires data entry
- Document site and Sponsor contact and study interactions in a timely and professional manner
Requirements
What you’ll need- Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline
- Minimum of 2 years of relevant experience
- High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
- Customer service demeanor; demonstrate flexibility and teamwork
- Ability to focus on detail for extended periods of time, high attention to accuracy
- Fluency in English communication, verbally and in writing
- Working knowledge of the drug development process
- Ability to travel as needed
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off