Clinical Research Associate

Clinical Research Associate

by Indus Biotech Private Limited, Pune in Pune

Experience: 1 to 5 yrs. | Opening(s): 1

Job Description

Candidate will be responsible to monitor clinical trials in accordance with national and international regulations and ICH-GCP guidelines by coordination with CROs for clinical study related documentation, clinical studies /trial supplies management etc.. Meets all local and company requirements with respect to clinical study and safety reporting in trials. The major activities will include:

• Ensure the smooth conduct of all clinical trials for company as sponsor, in accordance with Good Clinical Research Practice (GCP) guidelines and local regulatory requirements
• Manage and monitor clinical studies /trial supplies for sponsor
• Keeping track of compliance to monitoring and audit visit plan as sponsor representative
• To conduct regular review of clinical Trial files
• Coordination with clients/CROs regarding clinical study related activities.
• Verbal callouts with CRO for study related activities
• Periodic update on recruitment, SAE, site specific issues, and trial products issues in regular meetings (in house and with CROs)
• Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (< 25% travel) for GCP compliance according to ICH-GCP guidelines
• Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
• Coordinate with CRO for documents related to study specific guidelines and procedures, CRFs, and monitoring procedures.
• Prepare project management reports for sponsor
• To coordinate for site specific budgets and ensure timely payments to investigators/CRO
• Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites through CROs
• Review Tables and Listings generated from study data
• Assist in writing Clinical Study Reports
• Review and verify clinical study related data, in-house, for completeness and accuracy; generate queries.
• Monitor and coordinate payments related issues with CRO
• To assist in preparation of study specific documents for sponsor (Investigator Brochure, Protocol, CSR etc)
• Compiling information from past and present animal experiments for future clinical studies/trials designs

Salary:Not Disclosed by Recruiter

Role Category: R&D

Role: Clinical Research Associate/ Scientist

Desired Candidate Profile

Education:

(UG - B.Pharma - Pharmacy, B.Sc - Any Specialization, Bio-Chemistry, Food Technology, Nursing) AND (PG - Any PG Course - Any Specialization, Post Graduation Not Required, PG Diploma - Any Specialization, M.Pharma - Pharmacy, M.Sc - Any Specialization, Bio-Chemistry, Food Technology, Home science, Nursing)

Qualification required: PG Diploma in Clinical Research

Experience:

• One to five years’ work experience as CRA or CRC in clinical research, regulatory affairs, or other relevant position
• Excellent written and verbal communications skills
• Ability and willingness to travel up to 25%
• Excellent organizational skills and ability to manage time and work independently.
Candidate must have experience of trial monitoring (Phase 2&3) in a reputed Pharmaceutical industry /CRO.

Company Profile

Indus Biotech Private Limited, Pune http://www.indusbiotech.com

Indus Biotech is an innovative drug discovery company based in Pune focused on developing solutions from botanicals for the long – term management of chronic diseases.

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