Job Description:
The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Responsibilities include, but are not limited to:
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear,



comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

Extent of Travel

Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.

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Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
Travel Requirements:
Versátil Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R232754

📌 Clinical Research Associate (Bogotá)
🏢 Msd
📍 Bogotá