KlinEra Global Services is hiring Clinical Research Associates (CRA / CRA I / CRA II) for its Mumbai/Vidyavihar operations. The opportunity is suited to experienced clinical research professionals with hands-on experience in clinical trial monitoring, site management, ICH-GCP, regulatory documentation, and clinical operations.

Candidates with 2–5 years of CRA or clinical trial monitoring experience who are comfortable with substantial national and international travel can apply. Selected candidates will work closely with clinical project teams, investigators, and research sites to ensure studies are conducted according to protocols, GCP standards, regulatory requirements, and sponsor expectations.

KlinEra CRA Recruitment 2026 – Job Details

Clinical Research Associate – Key Responsibilities

The selected Clinical Research Associate will be responsible for monitoring and coordinating clinical trial activities at assigned research sites.

Site Feasibility and Selection

• Conduct study feasibility assessments.
• Perform Pre-Study Site Visits (PSSV) and support site selection.
• Assess site capabilities and readiness for clinical research.
• Coordinate activities required before study initiation.

Clinical Trial Site Initiation and Monitoring

The CRA will independently monitor clinical research sites and coordinate activities throughout the study lifecycle, including:

• Study Initiation Visits (SIV).
• Interim Monitoring Visits (IMV).
• Study Close-Out Visits (COV).
• Collection and appropriate filing of essential study documents.
• Review and maintenance of the Investigator Site File (ISF).
• Monitoring of study activities against protocol requirements.
• Follow-up of outstanding site activities and documentation.
• Timely preparation and finalization of monitoring trip reports and follow-up letters.

ICH-GCP and Regulatory Compliance

Candidates should have strong knowledge of ICH-GCP requirements and relevant international and local regulatory requirements.

Responsibilities include:

• Ensuring site compliance with applicable GCP and regulatory requirements.
• Training site staff on applicable ICH-GXPs and clinical operations procedures.
• Assessing the completeness and accuracy of regulatory documents.
• Monitoring regulatory documentation maintained in-house and at sites.
• Coordinating required Ethics Committee submissions and acknowledgements.
• Ensuring appropriate availability and filing of safety reports, CIOMS and other applicable regulatory correspondence.

Investigator and Site Coordination

The CRA will act as an important communication link between clinical research sites and the internal clinical project team.

Key activities include:

• Coordinating information flow between sites and the assigned KLINERA Clinical Project Manager (CPM).
• Coordinating Investigator Meeting activities.
• Supporting contract and study budget negotiations with sites.
• Maintaining effective communication with investigators and site personnel.
• Keeping site staff engaged and motivated to complete study activities within timelines.

IMP and Clinical Trial Documentation

The role involves oversight of study documentation and investigational medicinal product activities, including:

• Ensuring IMPs are stored under protocol-specified conditions.
• Monitoring IMP accountability at the site.
• Reviewing CRF completeness.
• Coordinating query resolution within defined timelines.
• Ensuring appropriate maintenance of the ISF.
• Archiving study documentation and correspondence.

Patient Safety and SAE Management

The CRA will also support safety-related activities at clinical trial sites, including:

• Identification of applicable Serious Adverse Events (SAEs).
• Ensuring appropriate SAE follow-up and documentation.
• Coordinating safety information between the site, KlinEra and sponsor.
• Ensuring relevant safety documentation is available and appropriately maintained.
• Supporting reconciliation of Ethics Committee submissions and acknowledgements.

Quality and Study Close-Out

The CRA will be expected to:

• Monitor sites for potential scientific misconduct or fraudulent practices.
• Ensure compliance with study protocols.
• Coordinate resolution of outstanding queries.
• Conduct study close-out activities.
• Coordinate Clinical Study Report (CSR) review and investigator sign-off.
• Ensure appropriate archiving of study records.

Qualifications and Skills

Candidates applying for the KlinEra CRA Jobs should have:

• Relevant educational background in Life Sciences, Pharmacy, Medicine, Nursing or a related discipline.
• At least 2 years of hands-on clinical trial monitoring experience, with the detailed requirement specifying 3–5 years of CRA experience.
• Strong knowledge of ICH-GCP.
• Understanding of clinical trial operations and monitoring processes.
• Experience with site management and clinical trial documentation.
• Knowledge of applicable local and international regulatory requirements.
• Experience with SIV, IMV and COV activities.
• Ability to independently monitor clinical research sites.
• Strong communication and interpersonal skills.
• Good organizational and documentation skills.
• Ability to work with investigators, site staff, sponsors and internal clinical project teams.
• Willingness to undertake 50–75% national and international travel.

Why This CRA Opportunity Matters

A CRA role provides hands-on exposure to several stages of clinical research, including site selection, study initiation, monitoring, patient safety, regulatory documentation, query management and study close-out.

Professionals joining clinical operations teams can gain experience working with investigators, clinical research sites, sponsors and cross-functional project teams while developing expertise in clinical trial execution and GCP compliance.

How to Apply for KlinEra CRA Jobs

Interested and eligible candidates can send their updated resume/CV to:

prachi.sonawane@klinera.com

Candidates should include the following information in their email:

• Current CTC:
• Notice Period:
• Expected CTC: