Clinical Trial Coordinator
Clinical Trial Coordinator
Roche
Job description
Looking to start a career in clinical research? Explore this Clinical Trial Coordinator role at Roche in Mumbai, coordinating trial initiation, regulatory submissions, site documentation, contracts, and study start-up compliance.
Company Description
Roche is a global healthcare company operating across Pharmaceuticals and Diagnostics. It develops medicines, biotechnology-based treatments, and in-vitro diagnostic solutions to help prevent, diagnose, treat, and monitor diseases. Founded in 1896, Roche focuses on scientific innovation and personalised healthcare, working with healthcare professionals to improve patient outcomes worldwide.
Job Summary
The Clinical Trial Coordinator supports Roche Pharma Global Clinical Operations by coordinating the initiation of clinical trials in Mumbai. The Clinical Trial Associate helps activate sites, prepare Health Authority and Ethics Committee submissions, adapt informed consent forms, manage amendments, and maintain essential site documents in the Trial Master File. They also support clinical trial contracts, site payments, vendor coordination, and regulatory compliance.
Key Responsibilities
Partner with internal teams, external partners, Contract Research Organizations (CROs) and clinical sites to develop study start-up plans and accelerate clinical site activation.
Preparation and management of submissions to Health Authorities and Ethics Committees.
Change ICFs, respond to RFIs, manage study amendments.
Collect and review all required site documents including CVs, patient materials, and biobank information submitting as required.
Timely document in Trial Master File (TMF) following local regulations and SOPs.
Offer assistance with conversations around clinical trial contracts, confidentiality agreements, indemnity clauses and amendments.
Work with internal and external stakeholders to ensure legal and financial compliance and improve contract management processes.
Support site payment oversight, escalation and reporting. Financial tracking, PO reconciliation, and accrual planning.
Identify potential research start up delays and negotiate with necessary partners to expedite.
Educational Qualification
A Bachelor's degree in Life Sciences or related discipline is necessary.
Postgraduate or master’s degree is a strong asset.
A thorough knowledge of clinical trial rules, Health Authority requirements, Ethics Committee recommendations and standard operating procedures.
Skills Required
Knowledge of clinical research, study startup processes, regulatory submissions, and site activation requirements.
Familiar with compliance of regulations of clinical trials, Health Authority and Ethics Committee standards, ICH-GCP principles and company SOPs.
Accurately generate, review, track and submit key clinical trial documentation in a timely fashion.
Ability to juggle multiple goals, keep track of research progress, identify potential delays and set up contracts and payments.
Excellent writing and verbal communication skills, and the ability to effectively collaborate with CROs, investigators, vendors, and global clinical research teams.
Salary Structure
The average salary of a Clinical Trial Coordinator is in the range of ₹5 Lakhs to ₹7 Lakhs per year.
Career Development
This role as a Clinical Trial Coordinator can provide expertise in clinical trial operations, regulatory filings, site activation, contract administration, and clinical documentation. You can advance into senior roles in study start-up, clinical operations, regulatory affairs or clinical trial management with experience of working with multinational teams and CROs.
How to Apply
Go to our job portal and search for Clinical Trial Coordinator.
Read the job description and eligibility criteria carefully.
Provide an updated resume and submit your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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