Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Clinical Research Associate _ Zti

Zydus Healthcare Limited
Zydus Healthcare Limited
3-5 years
preferred by company
10 Jan. 15, 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 – ZTI (R&D)

Location: Ahmedabad, Gujarat, India
Division: ZTI – Research & Development
Employment Type: Full-Time | Probationer (P-P5 – R&D Staff)
Experience Level: Entry to Mid-Level
Experience Required: 3–5 Years
Job Posted On: January 08, 2026

Job Overview

ZTI R&D is seeking a motivated and detail-oriented Clinical Research Associate (CRA) to support global clinical trial operations through remote site management and monitoring. This role is ideal for clinical research professionals with a strong understanding of ICH-GCP guidelines, regulatory compliance, and hands-on experience in site monitoring within sponsor or CRO environments.

The CRA will play a critical role in ensuring trial quality, data integrity, regulatory adherence, and effective coordination with investigational sites and US-based clinical teams.


Key Responsibilities

  • Manage assigned investigational sites remotely throughout the clinical trial lifecycle

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

  • Support project management teams in site feasibility assessments, including patient recruitment and retention analysis

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

  • Act as the primary point of contact for assigned investigational sites

  • Coordinate clinical activities with US-based regional Clinical Research Associates

  • Monitor site recruitment, enrollment, and retention performance

  • Review and reconcile regulatory documentation against the Trial Master File (TMF)

  • Verify biological sample collection, storage, and shipment procedures

  • Review and reconcile laboratory data and ensure accurate Case Report Form (CRF) completion

  • Review investigational product status using IRT systems and ensure adequate study supplies

  • Ensure timely CRF completion, query resolution, and compliance with study metrics


Required Skills & Competencies

  • Strong working knowledge of ICH-GCP guidelines and global clinical research standards

  • Solid understanding of US regulatory requirements related to clinical trials

  • Proficiency in Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and IRT platforms

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

  • Excellent verbal and written communication skills in English

  • Strong organizational skills with exceptional attention to detail

  • Ability to work independently in a remote, global clinical research environment

  • Strong interpersonal and stakeholder coordination skills

  • Flexibility to participate in meetings across international time zones


Education & Experience

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

  • Minimum 3 years of experience as a full-time regional monitor with a Sponsor or Contract Research Organization (CRO)

  • Experience supporting international clinical trials is highly desirable


Why Join ZTI R&D

  • Opportunity to work on global clinical research programs

  • Exposure to US and international regulatory frameworks

  • Collaborative, research-driven environment with strong professional growth potential

  • Hands-on involvement in high-quality clinical development projects


Apply now on thepharmadaily.com to advance your career in clinical research with a growing R&D organization committed to scientific excellence and patient-focused innovation.