Clinical Trial Coordinator

EyeBio; Gurugram District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

EyeBio in Gurugram, India is seeking a Clinical Trial Coordinator to oversee trial and site administration, including preparing, archiving, and distributing clinical documents. You will support regulatory submissions to IRB/ERC and Health Authorities and collaborate with COM, CRM and CRA teams.

The role involves managing CTRAs, payments, and budgeting while maintaining CTMS trackers and trial tools to meet Site Ready dates.

Qualifications

• Experience in clinical trial coordination, site management, and regulatory submissions.
• Strong documentation practices and eTMF familiarity.
• Ability to coordinate with cross-functional teams and vendors.

Responsibilities

• Track essential documents and report safety updates.
• Collate, distribute and archive study tools and documents.
• Update CTMS and trial trackers with current data.
• Manage clinical and non-clinical supply, in coordination with country roles.
• Coordinate labeling and translation change requests with relevant teams.

Skills

Clinical Trial Management

CTMS

IRB/ERC Submissions

Budgeting & Payments

Regulatory Compliance

Document Management

Site Start-Up

Cross-Functional Collaboration

Data Archiving

Vendor Coordination

Tools

eTMF

CTMS

Job description

Job Description

Clinical Trial Coordinator

Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

Responsibilities include, but are not limited to

Trial and site administration:

• Track (e.g. essential documents) and report (e.g. Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Clinical supply & non-clinical supply management, in collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

Document management:

• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation
• Execute eTMF Quality Control Plan
• Update manuals/documents (e.g., patient diaries, instructions)
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders
• Obtain translations of documents

Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation

Budgeting, Agreement and Payments:

• Develop, control, update and close-out country and site budgets (including Split site budget)
• Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
• Track and report contract negotiations
• Update and maintain contract templates (in cooperation with Legal Department)
• Calculate and execute payments (to investigators, vendors, grants)
• Ensure adherence to financial and compliance procedures
• Monitor and track adherence and disclosures
• Maintain tracking tools
• Obtain and process FCPA documentation in a timely manner

Meeting Planning:

• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Required Skills:

Adaptability, Best Practices Research, Clinical Research, Clinical Site Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, Data Archiving, Economic Forecasting, Financial Administration, Financial Forecasting, ICH GCP Guidelines, Legal Archiving, Medical Research, Patient Recruitment, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Compliance

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 08/26/2026