Premier Research is hiring a Clinical Trial Associate II for its Clinical Monitoring, Site Management and Study Start-Up (SSU) team in Bangalore, India. This is a full-time hybrid clinical research opportunity for candidates with an educational background in nursing, life sciences, or medical documentation and previous Clinical Trial Associate or similar experience.

The Premier Research Clinical Trial Associate II job primarily focuses on Trial Master File (TMF), electronic Trial Master File (eTMF), essential document management, quality review, clinical trial documentation, and support for study start-up, maintenance, and close-out activities.

Candidates with working knowledge of ICH-GCP, ALCOA+, CTMS, eTMF systems, essential clinical trial documents, and TMF quality management are particularly relevant for this opening. Premier Research has also stated that it is looking for immediate joiners who can start at the earliest.

Job Overview

Key Responsibilities

As a Clinical Trial Associate II at Premier Research, the selected candidate will support clinical trial documentation and TMF/eTMF activities throughout the study lifecycle.

Key responsibilities include:

• Maintain the Trial Master File (TMF) and electronic Trial Master File (eTMF) in collaboration with the clinical study team.
• Ensure TMF activities comply with Premier Research or sponsor SOPs and applicable regulatory requirements.
• Create and maintain TMF placeholders according to filing plans, study milestones, expired documents, site staff changes, and other study events.
• Review clinical trial site documents and ensure they comply with company, sponsor, regulatory, and ALCOAC/ALCOA+ standards.
• Perform quality reviews and completeness checks of relevant eTMF sections.
• Support TMF quality throughout study start-up, maintenance, and close-out.
• Follow up with clinical teams to resolve TMF findings and documentation gaps.
• Coordinate with internal teams regarding TMF queries and ensure timely resolution.
• Generate and distribute eTMF reports to clinical teams to support quality and regulatory compliance.
• Assist Study Start-Up Associates (SSUAs) and Clinical Research Associates (CRAs) with essential document collection and review when required.
• Support translation or review of translated site documents where applicable.

Eligibility Criteria

Candidates interested in the Premier Research Clinical Trial Associate II vacancy in Bangalore should meet the following requirements.

Educational Qualification

An undergraduate degree or international equivalent from an accredited institution is required in:

• Nursing
• Life Sciences
• Medical Documentation

Premier Research also states that an equivalent combination of education and experience may be considered.

Experience Required

Candidates should have a minimum of 1–2 years of previous experience as a Clinical Trial Associate or in a similar clinical research role.

Therefore, this particular Clinical Trial Associate II opening is not primarily advertised as a fresher position.

Clinical Research Knowledge Required

Applicants should have working knowledge of:

• ICH-GCP guidelines
• Trial Master File (TMF)
• Electronic Trial Master File (eTMF)
• Essential clinical trial documents
• ALCOA+ / ALCOAC principles
• Clinical Trial Management Systems (CTMS)
• Clinical trial documentation
• Study start-up documentation
• TMF quality review
• Document completeness checks
• Clinical study maintenance and close-out activities

Experience working with CTMS and eTMF clinical research systems is specifically relevant to the role.

Skills Required

Premier Research is looking for candidates with:

• Fluent written and verbal English
• Strong organizational skills
• Good time-management abilities
• Excellent interpersonal and listening skills
• Ability to meet project and study deadlines
• Ability to work independently
• Ability to collaborate effectively within clinical study teams
• Solid computer skills

Candidates should also be comfortable using:

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Microsoft Outlook

Salary for Clinical Trial Associate II

Premier Research has not disclosed a salary range in the provided job description.

For informational purposes, a reasonable editorial estimate for a Clinical Trial Associate II-level position in Bangalore may be approximately:

₹4,50,000 – ₹8,00,000 per year

Actual compensation can vary considerably depending on previous CTA/TMF experience, current compensation, clinical research systems knowledge, company salary structure, and interview performance.

Note: This salary range is an independent Pharmabharat estimate and is not an officially disclosed Premier Research salary range.

Why Consider This Opportunity?

The Premier Research Clinical Trial Associate II role provides exposure to important clinical operations and documentation activities, including TMF/eTMF management, essential document review, ICH-GCP compliance, CTMS, study start-up, study maintenance, and close-out support.

Professionals interested in building careers in areas such as Clinical Operations, Trial Master File management, Study Start-Up, Clinical Trial Administration, or Clinical Research may find the experience relevant to their longer-term career development.

Premier Research also highlights employee growth, professional development, flexibility, and work-life balance as part of its employment proposition.

Who Should Apply?

This position may be particularly suitable for candidates who:

• Hold an undergraduate degree in nursing, life sciences, medical documentation, or an equivalent discipline.
• Have approximately 1–2 years of Clinical Trial Associate or related experience.
• Have practical exposure to TMF/eTMF documentation.
• Understand ICH-GCP and ALCOA+ principles.
• Have worked with CTMS, eTMF, or similar clinical research systems.
• Can work from the Bangalore office 2 days per week.
• Are available to join immediately or at the earliest possible date.

How to Apply

Application Link