Senior In-house CRA (LATAM) | JobSetuu

Description

Job Overview

• Source: Jobicy

Job Description

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for an experienced Senior In-house CRA to help build the foundation of this new regional function in LATAM!

The Senior 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 a point of contact for study sites.

The Senior In-house CRA has broad experience and typically handles complex and advanced assignments. Individual is expected to work independently in providing support to CRA and sites. Senior In-house CRA can have increased focus on training and development of junior staff members and can act as Lead In-house CRA.

Essential functions of the job included but not limited to:

• Assists 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, 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 training and mentoring to less-experienced team members and lead multiple In-house CRAs on a project.
• 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
• 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
• 4 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:

• Solid experience in clinical research or related experience
• Excellent organizational skills are preferred
• Ability to work efficiently in a remote work environment
• Ability to resolve 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
• Sound critical thinking skills
• Commitment to performing professionally consistent with Precision Principles

#LI-AG2 #LI-REMOTE

Expert Career Tips for Senior In-house CRA (LATAM) Roles

To succeed in a competitive market as a Senior In-house CRA (LATAM), you need more than just technical skills. Here are some expert strategies to elevate your profile:

• Build a Strong Portfolio: For technical roles, a clean GitHub or a personal project site is essential. For non-technical roles, a case study portfolio demonstrating problem-solving and impact is equally valuable. Show, don't just tell, what you have achieved in your previous positions.
• Master the Narrative: When interviewing, use the STAR method (Situation, Task, Action, Result) to structure your answers. Quantify your results wherever possible—mentioning "increased efficiency by 20%" is much more impactful than saying "improved efficiency."
• Continuous Learning: The industry moves fast. Whether it's staying updated with the latest AI tools or mastering a new management methodology, continuous professional development is key. Consider obtaining industry-recognized certifications that align with Senior In-house CRA (LATAM) requirements.
• Networking: Connect with other professionals in similar roles. Join online communities, attend webinars, and engage in meaningful discussions on professional social networks. Often, the best opportunities come through referrals and community engagement.
• Soft Skills Matter: Communication, empathy, and leadership are often the deciding factors between two equally qualified technical candidates. Cultivate these skills as they are universally valued across all industries and seniority levels.

Additionally, research the specific company's culture and values. Tailoring your application to show how you align with their mission can significantly increase your chances of moving forward in the process.

Salary & Compensation

Salary not disclosed; typically competitive for the role.

Work Arrangement

Type: On-Site

Standard business hours at the office.

Comprehensive Application Strategy & Hiring Process

Applying for a new role is a marathon, not a sprint. Follow this strategic approach to maximize your success rate:

1. Initial Research & Tailoring

Don't send the same resume to every employer. Spend at least 30 minutes researching the company. Look for recent news, their product roadmap, and their team structure. Modify your summary and core competencies to reflect the specific keywords found in the job description.

2. The Perfect Cover Letter

If the application allows for a cover letter, use it to tell a story that your resume cannot. Explain why you are passionate about this specific company and how your unique background makes you the perfect fit for the challenges they are currently facing.

3. Navigating the Multi-Stage Interview

Most modern hiring processes involve 3-5 stages. This typically includes a recruiter screen, a technical or skill-based assessment, a peer interview, and a final leadership round. Prepare for each stage differently: focus on enthusiasm and fit for the recruiter, technical depth for the assessment, and strategic vision for the leadership round.

4. Post-Interview Follow-Up

Always send a personalized thank-you note within 24 hours of each interview. Reference a specific topic discussed during the call to demonstrate your active listening and genuine interest in the role.

By following these steps, you demonstrate a high level of professionalism and attention to detail that sets you apart from the average applicant.

Typical Interview Process

1. Resume screening
2. HR call
3. Skill interview
4. Final manager interview
5. Offer

Tip: Research the company's products and culture.

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The demand for skilled professionals is increasingly borderless. For roles based in Global, understanding the local cost of living, visa requirements (if applicable), and cultural nuances is vital. If this is a remote role, consider the time zone alignment and the asynchronous communication culture of the hiring organization.

Relocation Support: Many forward-thinking companies offer relocation packages that include moving stipends, temporary housing, and legal assistance with work permits. When evaluating an offer, look beyond the base salary—consider the total compensation package, including equity, bonuses, and healthcare benefits.

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Skills & Competency Roadmap for Professional Development

To remain competitive in Professional Development, we recommend focusing on the following core competencies over the next 12-18 months:

• Technical Mastery: Deepen your expertise in the core tools and languages relevant to your field. For developers, this might be cloud architecture; for marketers, it might be data-driven attribution modeling.
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By investing in these areas, you not only prepare yourself for the role you are applying for today but also build a resilient foundation for the opportunities of tomorrow.

Apply via JobSetuu

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