Job Opportunity only available for professionals located in Latin America.
Are you an experienced Clinical Research Associate (CRA) looking for an exciting opportunity to contribute to impactful clinical research while working remotely with an international team?
We're looking for a talented and detail-oriented Clinical Research Associate (CRA) to join our team and support clinical research activities for a growing US-based pharmaceutical organization.
In this role, you'll have the opportunity to work closely with investigative sites, clinical operations teams, and international stakeholders, playing a key role in ensuring that clinical studies are conducted according to the highest quality, ethical, and regulatory standards.
If you're passionate about clinical research, enjoy building strong relationships with sites and stakeholders, and thrive in a dynamic international environment, we'd love to hear from you!
What We're Looking For
We're looking for someone who is highly organized, proactive, and passionate about clinical research.
Requirements:
- Advanced English proficiency (C1 or equivalent) - both written and spoken.
- 2+ years of experience as a Clinical Research Associate (CRA) or in a similar clinical monitoring role.
- Experience working within a pharmaceutical company, biotechnology company, CRO, or healthcare organization.
- Strong knowledge of ICH-GCP, clinical research processes, and regulatory requirements.
- Hands-on experience conducting clinical site monitoring activities.
- Experience working directly with investigators and clinical research site staff.
- Strong organizational and time-management skills, with the ability to manage multiple priorities.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to work independently in a remote and international environment.
- Experience using Microsoft Office and clinical research systems.
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related field.
Nice to Have:
- Experience supporting global or multinational clinical trials.
- Experience working with US-based clients or stakeholders.
- Experience across Phase I–III clinical trials.
- Familiarity with CTMS, EDC, eTMF, and other clinical trial management systems.
- Experience in one or more specific therapeutic areas.
- ACRP, SOCRA, or other relevant clinical research certifications.
What You'll Do
As a Clinical Research Associate, you will play a key role in the successful execution of clinical trials. Your responsibilities will include:
- Conducting and supporting site monitoring activities, including Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs).
- Ensuring clinical trial sites operate in compliance with study protocols, ICH-GCP guidelines, applicable regulations, and company SOPs.
- Building and maintaining strong relationships with investigators and site staff.
- Reviewing source documentation and clinical trial data to ensure accuracy, completeness, and compliance.
- Identifying and following up on protocol deviations, data discrepancies, and site-related issues.
- Supporting the resolution of monitoring findings and implementation of corrective actions when necessary.
- Supporting site activation and ensuring regulatory and essential documentation is properly maintained.
- Monitoring site performance, patient recruitment, and retention activities.
- Preparing high-quality monitoring visit reports and follow-up communications.
- Collaborating with Clinical Operations, Clinical Trial Management, Data Management, Regulatory Affairs, and other cross-functional teams.
- Communicating regularly with US-based stakeholders and providing updates on study progress, site performance, risks, and challenges.
- Supporting inspection readiness and maintaining high standards of quality and compliance.
What We Offer
At Venon Solutions, we believe great professionals deserve great opportunities. By joining us, you'll have the chance to:
- Work 100% remotely from Latin America.
- Receive compensation in USD.
- Join a long-term project with an international client.
- Collaborate with experienced professionals and US-based teams.
- Enjoy 2 weeks (10 business days) of Paid Time Off.
- Receive paid US holidays.
- Work under an Independent Contractor agreement with Venon Solutions LLC.
- Work full-time following EST business hours.
