9d ago

Practicante de Monitoreo

Per - Lima - Lima (andres Reyes Wework)mid

Other

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Quick Summary

Overview

Job Description Under the oversight of the CRA Manager, provide administrative and operational support to clinical study teams, with a focus on monitoring KPIs,

Technical Tools

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Job Description

Under the oversight of the CRA Manager, provide administrative and operational support to clinical study teams, with a focus on monitoring KPIs, maintaining eTMF quality and completeness. Collaborate cross-functionally to drive process improvements and ensure compliance with internal standards and regulatory requirements.

Responsibilities

~1 min read

→Support the drafting of progress reports for submission/notification to the MoH
→Monitor KPIs (primarily within the eTMF), generate periodic reports, and escalate issues as appropriate.
→Review documents uploaded to external team platforms versus those filed in the eTMF, ensuring alignment and completeness.
→Support the follow-up and collection of essential documents required for timely upload to the eTMF, maintaining quality and version control.
→Run SUSAR reports and share status updates with CRAs; support oversight of safety reporting timelines and tracking.
→Accompany monitors to site visits as needed
→Actively participate in process improvement initiatives and/or projects to enhance efficiency and compliance.
→Interact with internal support functions as needed (e.g., Regulatory Team, Pharmacovigilance, Supplies, Finance, etc.)

Proficiency in Microsoft Word, Excel, and PowerPoint.
Working knowledge of Power BI; familiarity with AI-enabled tools and other analytics/reporting platforms is a plus.
Comfortable working with different clinical and document management systems (e.g., eTMF, CTMS).

Strong analytical skills and attention to detail.
Fast learner with the ability to assimilate new processes and systems.
Solid planning and organizational skills; able to manage multiple priorities and deadlines.
Ability to adapt to and work effectively across different systems and workflows.
Strong interpersonal skills and collaborative mindset.

Customer focus, including patient-centric thinking.
Make fast, disciplined decisions.
Foster collaboration across teams.
Drive results and accountability.
Demonstrate ethics and integrity in all activities.

Requirements

~1 min read

Familiarity with clinical research processes and GCP.

Ability to Coordinate, Ability to Coordinate, Clinical Research, Cloud Data Catalog, Corporate Ethics, Customer Centricity, Customer-Focused, Data Analysis, Database Management, Data Science, Data Security, Data Visualization, Data Wrangling, Decision Making, Detail-Oriented, Ethical Standards, Event Planning, Ideation, Key Performance Indicators (KPI), Learning Agility, Microsoft PowerPoint, Multitasking, Planning Ability, Policy Compliance, Progress Monitoring {+ 9 more}