Clinical Research Associate II

Overview

???? Job Title: Clinical Research Associate (CRA) II

???? Location: Remote – India / Bangladesh
???? Job Type: Contractual / Temporary

???? About Emmes Group:

Emmes Group is transforming the future of clinical research. With over 47 years of legacy, we partner with governments, public-private initiatives, and commercial biopharma to improve patient outcomes. Our core strengths lie in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.

We’re performance-driven and people-focused — building a collaborative culture where innovation and impact thrive.

???? Primary Purpose:

As a CRA II, you will monitor clinical study sites (both remotely and onsite) to ensure that clinical trials comply with protocols, ICH-GCP, SOPs, and regulatory standards. This includes conducting monitoring visits, ensuring data accuracy, and guiding site personnel.

???? Key Responsibilities:

• Monitoring Visits:

  • Independently plan and conduct site visits: qualification/pre-study, initiation, interim/routine, closeout, and for-cause visits.

  • Perform ICF review, source data verification, adverse event tracking, and investigational product accountability.

• Site & Data Management:

  • Ensure accurate reporting and documentation post-visit.

  • Monitor adherence to protocol, GCP/GDP, SOPs, and regulatory requirements.

  • Address issues through training/retraining of site staff.

• Documentation & Reporting:

  • Prepare site visit reports and follow up on action items.

  • Review study documentation including protocols, monitoring plans, and consent forms.

• Team Collaboration:

  • Work closely with internal and external project teams.

  • Attend project meetings and investigator meetings as required.

• Compliance & Audit Readiness:

  • Assist in audit preparation and act as a liaison during inspections.

  • Support filing, archiving, IRB/EC submissions, and regulatory notifications.

• Additional Responsibilities:

  • Help in site recruitment, patient engagement strategies, and study supply coordination.

  • Perform other CRA-related tasks as assigned.

???? Qualifications:

• Education:

  • Bachelor's degree in a scientific discipline (preferred) or equivalent experience.

• Experience:

  • 1–2 years of clinical monitoring (both onsite and remote).

????️ Required Skills & Abilities:

• Proficient with Microsoft Office Suite.

• Strong attention to detail and organizational skills.

• Self-motivated, adaptable, and able to work independently.

• Excellent verbal and written communication skills.

• Critical thinker with sound decision-making and time management.

• Strong understanding of clinical operations and ICH-GCP guidelines.

• Collaborative mindset with ability to work cross-functionally.

???? Connect With Emmes:

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