Practicante de Investigación Clínica

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.

Key Responsibilities

• 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.

• Reconcile and monitor 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.)

Required Skills and Systems

• 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).

Technical Competencies

• 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.

Leadership Behaviors

• 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.

Familiarity with clinical research processes and GCP

Required Skills:

Preferred Skills:

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