Job Title: Clinical Research Associate II
Department: Clinical Operations
Employment Type: Regular Full-Time
Job ID: 2414
Location: India – Bengaluru (Remote/Ahmedabad/Bengaluru/New Delhi)
Company Overview:
Emmes Group is a global clinical research organization with over 47 years of experience in driving medical innovation. With a legacy of partnerships across the US government, public-private initiatives, and commercial biopharma, Emmes is a leader in therapeutic areas such as cell and gene therapy, vaccines, ophthalmology, infectious diseases, neuroscience, and rare diseases. The organization fosters a collaborative, high-performance, and patient-centric culture.
Position Summary:
The Clinical Research Associate (CRA) II is responsible for conducting on-site and remote monitoring visits to ensure clinical trials comply with protocols, SOPs, ICH GCP, and applicable regulatory guidelines. This role involves comprehensive monitoring activities, documentation, and support functions essential for successful clinical trial operations.
Key Responsibilities:
Independently conduct monitoring visits (pre-study, initiation, interim, close-out, and for-cause).
Perform ICF review, source data verification, AE and protocol deviation tracking, IP accountability, and facility inspections.
Document monitoring activities and site visit findings in detailed reports.
Ensure timely resolution of action items following monitoring visits.
Train and retrain site staff on protocol and GCP/GDP requirements.
Identify site-specific issues and recommend improvements.
Maintain compliance with regulatory requirements and Emmes SOPs.
Serve as a primary contact for study site personnel under project oversight.
Support development/review of study materials (protocols, ICFs, monitoring plans).
Collaborate on project updates in team meetings and coordinate with internal/external stakeholders.
Participate in Investigator Meetings and support audit/inspection preparations.
Assist with clinical supply coordination, IRB/EC submissions, and site recruitment strategies.
Qualifications:
Bachelor’s degree in a scientific discipline or equivalent experience.
1–2 years of on-site and remote monitoring experience.
Strong computer skills, particularly MS Office Suite.
High attention to detail and strong organizational skills.
Critical thinking with the ability to manage multiple projects.
Independent, proactive, and collaborative work style.
Solid understanding of clinical research operations and applicable regulations.
Effective communication (oral and written) and interpersonal skills.
Strong problem-solving, decision-making, and time management capabilities.
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