Practicante de Investigación Clínica

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: Accountability, Accountability, Clinical Research, Clinical Site Management, Communication, Database Management, Data Entry, Document Management, Email Management, Event Planning, File Management, Inventory Management, Key Performance Indicators (KPI), Manufacturing Compliance, Microsoft Office, Microsoft Power Business Intelligence (BI), Microsoft Word, Morale Building, Office Management, Payment Handling, Pharmacovigilance, Process Improvement Projects, Processing Expense Reports, Progress Reports, Project Coordination {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Intern/Co-op (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:12/10/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

R374905