# Principal In-house CRA (LATAM)

Remote from[LATAM](https://jobicy.com/job-region/latam.md)Annual salary Undisclosed Salary information is not provided for this position.
Check our [Salary Directory](https://jobicy.com/salaries.md) to estimate the average compensation for similar roles.Department  [Healthcare & Medical](https://jobicy.com/categories/healthcare.md) Employment type Full Time, Job posted26 Jun 2026Apply before26 Jul 2026Experience level  Senior
Views / Applies 36 / 11 [About company](https://jobicy.com/company/precision-medicine-group.md) [Share](#share)

About [Precision Medicine Group](https://jobicy.com/company/precision-medicine-group.md)

We collaborate from home offices and high-tech facilities to help life science companies move discoveries from molecule to medicine cabinets.

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[Biotechnology](https://jobicy.com/company-category/biotechnology.md)
*  2012

Verified job posting This job post has been [manually reviewed](https://jobicy.com/tools/help-center/employee/how-does-jobicy-verify-the-legitimacy-of-remote-job-listings.md) for authenticity and compliance.       Tailor Resume Check Job Fit Cover Letter

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###  AI Summary

This Principal In-house CRA position supports clinical research studies across LATAM regions including Mexico, Brazil, and Argentina. The role involves site management, essential document collection, and acting as a point of contact for study sites. As a senior team member, you will mentor junior staff and provide oversight on site management activities. This is a foundational role helping to build a new regional function for the company. The position requires extensive experience with ICH-GCP guidelines and regulatory compliance.

### Role DNA

Job Complexity Easy Hard Pace & Pressure Relaxed Fast-paced Autonomy Level Guided Full Ownership Communication Load Independent Highly Collaborative

AI Insight The role requires extensive experience, oversight, and mentoring responsibilities, placing it at a high difficulty level but not the maximum due to the in-house nature.

### Salary Analysis

Median  Market Rate  USD135,000US Market USD100k – 180k 0 USD198k      AI Insight The job posting does not include salary information. Based on US market data for similar Principal CRA roles, the estimated median salary is $135,000 per year, which is competitive for this senior level position.

### Key Skills

Clinical Research ICH-GCP Site Management Trial Master File CTMS Regulatory Compliance Mentoring Investigator Recruitment Data Review Study Startup

### Cover Letter Sample

Dear Hiring Manager,

I am writing to express my strong interest in the Principal In-house CRA position for LATAM. With over 8 years of clinical research experience, including extensive site management and team mentoring, I am confident in my ability to support the expansion of your regional function. My expertise includes ensuring compliance with ICH-GCP guidelines, managing Trial Master Files, and improving site performance through effective communication. I look forward to contributing to your company's success and driving high-quality clinical trials in the LATAM region.

Sincerely, [Your Name]

Copy

### Possible Interview Questions

Describe your experience with site management and how you ensure compliance with ICH-GCP guidelines.I have over 5 years of site management experience, where I regularly conducted site feasibility, initiated studies, and ensured essential documents were compliant. I stay updated with ICH-GCP changes and apply them to daily workflows by conducting regular audits and training.How do you prioritize tasks when managing multiple studies and sites simultaneously?I use a combination of CTMS tracking and daily to-do lists. I prioritize based on study milestones, regulatory deadlines, and site needs. For example, I always prioritize document collection for upcoming site initiations and data entry deadlines.Can you give an example of how you mentored a junior CRA or team member?I mentored a new CRA by conducting weekly check-ins, reviewing their monitoring reports, and providing feedback. I also created a checklist for essential document collection which improved their efficiency by 30%.How do you handle situations where a site is not meeting enrollment expectations?I first analyze the site's recruitment data and discuss with the coordinator to identify barriers. Then I may propose additional strategies like increased advertising or referral incentives, and provide support with patient pre-screening.What experience do you have working with regulatory submissions in LATAM countries?I have experience with IRB/IEC submissions in Mexico and Brazil, including understanding local requirements for document translation and approval timelines. I have successfully managed submissions for 3 studies in these regions.  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 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 managing study supplies, and may support offsite central monitoring activities. Escalates issues and risks as needed
* Ensures timely and complete data entry by site in EDC or any other system that requires data entry
* Sends email blasts/newsletter, updates, and updated study core documents to study site personnel
* Assists in providing logistics support in samples management and tracking, where applicable and in study supply management
* Supports investigators and investigative staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements
* Assists in data review inclusive of site level data review, resolutions provided by sites to queries, facilitates database closure and freezing procedures as per study plans
* Assist with study tracking via the CTMS, Study specific trackers or Sponsor designated system to ensure that the study reporting is current, accurate and complete
* Documents site and Sponsor contact and study interactions in a timely and professional manner
* Assist in remote review of the electronical Investigator Site File, where applicable
* Assists with, or if needed, conducts Investigational Product accountability, where applicable
* Consults with project team members regarding study site issues
* Provides quality review of the amended site level informed consent template
* Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments
* May 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 guidelines
* May serve as an Independent Essential Document Reviewer post-SIV
* Supports on-site visit activities if needed
* Provides team leadership, training, and assessment/ coaching feedback to in-house CRA team members
* Leads multiple in-house CRAs on a project, providing training and mentoring as required
* Assists management with the development of training materials
* Assists project team with the development of study specific documents and procedures
* May support manager and interface with partner departments to support enhanced project delivery
* Participates 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/SUL
* May 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 improvements
* May create and execute risk management strategies for their aspect of project delivery with oversight from functional team leads/functional managers
* Performs other duties as assigned by management
* Performs 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 discipline
* 6 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 teamwork
* Ability to focus on detail for extended periods of time, high attention to accuracy
* Fluency in English communication, verbally and in writing
* In-depth knowledge of the drug development process
* Experienced with utilizing CTMS, TMF, and EDC systems
* Ability to travel as needed

Preferred:

* Extensive experience in clinical research or related experience
* Excellent communication and organizational skills are essential
* Ability to work remotely
* Skilled in solving higher level complex problems using knowledge/skills, precedents, and practices
* Can support junior In-House CRA on issues identification and resolution

Competencies:

* In – depth knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance
* Demonstrates strong interpersonal skills and time management skills
* Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
* Excellent written and verbal communication skills and presentation skills
* Ability to deliver on commitments
* Advanced critical thinking skills
* Good leadership skills
* Commitment to performing professionally consistent with Precision Principles

#LI-AG2 #LI-REMOTE

Any data provided as a part of this application will be stored in accordance with our [Privacy Policy.](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0) For CA applicants, please also refer to our [CA Privacy Notice](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0).

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [myHR@precisionmedicinegrp.com](mailto:myHR@precisionmedicinegrp.com).

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [myHR@precisionmedicinegrp.com](mailto:myHR@precisionmedicinegrp.com) so we can investigate and take appropriate action.

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>  Annual salary information is not provided for this position. Explore salary ranges for similar roles in our [Salary Directory ›](https://jobicy.com/salaries.md)

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