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Clinical Research Associate _ Zti

Zydus Lifescience Ltd
3-5 years
preferred by company
10 Jan. 19, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Associate (CRA) – ZTI

Location: Ahmedabad, Gujarat, India
Department: R&D – ZRC | ZTI
Job Type: Full-time | R&D Staff (Probationer Level: P-P5)
Experience Required: 3–5 Years
Posted On: January 08, 2026


Job Overview

ZTI is seeking a Clinical Research Associate (CRA) to support global clinical development activities through remote monitoring of investigational sites. This role plays a key part in ensuring clinical trial quality, regulatory compliance, and data integrity across assigned sites, while collaborating closely with project management teams and US-based CRAs.

The position is ideal for professionals with strong knowledge of ICH-GCP, US regulatory requirements, and remote site monitoring methodologies within sponsor or CRO environments.


Key Responsibilities

Site Monitoring & Clinical Oversight

  • Manage assigned investigational sites remotely in accordance with study protocols and regulatory requirements

  • Conduct remote site qualification, initiation, routine monitoring, and close-out visits

  • Act as the primary point of contact for assigned sites, ensuring timely communication and issue resolution

Study Start-Up & Site Support

  • Support project management teams during site feasibility assessments, including evaluation of patient recruitment and retention potential

  • Assist in planning and execution of site initiation visits and site training activities

  • Coordinate operational activities with US-based regional CRAs across different time zones

Data Quality & Regulatory Compliance

  • Perform remote review and reconciliation of regulatory documentation against the Trial Master File (TMF)

  • Ensure timely completion of electronic Case Report Forms (eCRFs) and resolution of data queries

  • Monitor study metrics related to data completeness, query turnaround time, and site compliance

Clinical Operations & Supplies

  • Monitor site recruitment and enrollment performance and support recruitment planning as required

  • Verify biological sample collection, storage, and shipment procedures

  • Review and reconcile laboratory data to ensure accurate capture in CRFs

  • Review investigational product status within IRT systems and ensure adequate study supply maintenance


Required Qualifications & Skills

  • Strong working knowledge of ICH-GCP guidelines and clinical trial regulatory requirements

  • Solid understanding of US FDA regulations related to clinical trial conduct and oversight

  • Proficiency in EDC systems, Clinical Trial Management Systems (CTMS), IRT platforms, and electronic TMF environments

  • Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat

  • Excellent organizational skills with strong attention to detail

  • Strong verbal and written communication skills

  • Fluent in English; additional language skills are an advantage

  • Ability to work independently in a remote, globally distributed team environment

  • Strong interpersonal and stakeholder coordination skills

  • Flexibility to support meetings across international time zones as required


Education & Experience Requirements

  • Bachelor’s degree in Life Sciences or a related discipline (required)

  • Minimum of 3 years of experience as a full-time Clinical Research Associate or Regional Monitor with a sponsor or CRO

  • Experience in remote monitoring and global clinical trial execution is strongly preferred


Why Join ZTI

  • Opportunity to work on international clinical trials within a globally connected R&D environment

  • Exposure to US-regulated studies and global monitoring models

  • Collaborative work culture with cross-functional and international teams

  • Platform to strengthen expertise in remote monitoring, regulatory compliance, and data quality management