Senior Clinical Research Associate

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Clinical Research Associate in United States.

This Senior Clinical Research Associate role is focused on supporting and executing high-quality clinical trial monitoring and site management activities across the United States.
The position plays a key role in ensuring studies are conducted in compliance with ICH-GCP, local regulations, and study protocols.
You will work closely with investigator sites and cross-functional clinical teams to ensure smooth study execution and timely delivery of milestones.
The role includes both on-site and remote monitoring, with frequent travel and strong engagement with site personnel.
You will also contribute to oversight activities, ensuring CRO partners and sites maintain data integrity and operational quality.
This is a highly collaborative and impact-driven position within a global clinical research environment focused on improving patient outcomes.
It offers exposure to complex studies and the opportunity to directly influence the quality and success of clinical development programs.

Accountabilities:

Execute site monitoring activities including qualification, initiation, interim, and close-out visits, ensuring compliance with protocols, ICH-GCP, and regulatory standards
Manage site relationships, maintaining effective communication and supporting issue resolution throughout the study lifecycle
Conduct oversight monitoring activities, including review of CRO CRA performance, study metrics, and site-level deliverables
Perform drug accountability, reconciliation, and ensure proper handling, storage, and destruction processes
Review source documentation and ensure accurate and complete data capture aligned with ALCOA principles
Prepare, write, and submit detailed monitoring visit reports, oversight reports, and study correspondence
Identify protocol deviations, escalate non-compliance issues, and ensure appropriate corrective actions are implemented
Collaborate with clinical teams, CTLs, and CRO partners to support study activation, execution, and inspection readiness

Requirements:

Bachelor’s degree or equivalent in a scientific or health-related field
Minimum of 5 years of experience as a Clinical Research Associate or in a related clinical research role
Strong knowledge of clinical drug development processes and ICH-GCP guidelines
Familiarity with regulatory frameworks such as FDA, EMA, and PMDA requirements
Experience with clinical systems including EDC, CTMS, and Microsoft Office applications
Strong analytical thinking, problem-solving skills, and attention to detail
Excellent communication and interpersonal skills to manage stakeholder relationships effectively
Strong organizational skills with the ability to prioritize tasks and manage travel-intensive workloads
Ability to produce clear, concise, and high-quality written reports

Benefits:

Competitive compensation aligned with experience and market standards
Comprehensive health, dental, and vision insurance coverage
Retirement savings plans with employer contributions
Flexible work arrangements with significant travel opportunities across the United States
Opportunities for professional development and continued training in clinical research
Exposure to global clinical trials and cross-functional collaboration
Supportive and inclusive work environment focused on innovation and impact in healthcare.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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Senior Clinical Research Associate

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