# Clinical Research Contract Coordinator

**Company**: Fortrea
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Bangalore/REGULATORY-AND-START-UP_262931?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_13ac8172-50c

## Description

We are seeking a Clinical Research Contract Coordinator to join our team. As a Clinical Research Contract Coordinator, you will be responsible for drafting, reviewing, negotiating, and finalizing Clinical Trial Agreements (CTAs), confidentiality agreements, amendments, and related site contract documentation.

Responsibilities:

- Coordinate with sponsors, legal teams, clinical operations, and study teams to facilitate timely contract execution.

- Manage site agreement timelines and ensure contracts are completed within study milestones and agreed turnaround timelines.

- Maintain accurate contract status updates and documentation in SAMS, UCV, and other applicable systems.

- Facilitate internal approval workflows and obtain required authorizations for agreement execution.

- Track contract execution status and ensure executed documents are filed appropriately in shared repositories.

- Identify contracting risks, delays, and issues proactively and escalate to management where required.

- Provide regular updates to study teams and management regarding contract progress and outstanding issues.

- Coordinate protocol amendment submissions and associated documentation updates for assigned studies and sites.

- Support amendment-related contract and budget revisions in alignment with approved protocol changes.

- Review amendment requirements and communicate action items, timelines, and documentation needs to sites and study teams.

- Track amendment progress and ensure timely completion of submissions, approvals, and implementation activities.

- Collaborate with cross-functional teams including Clinical Operations, Regulatory, Legal, and Finance to support amendment execution.

- Ensure all amendment-related documents are uploaded and maintained accurately within applicable systems and trackers.

- Support site communications and follow-up activities to address outstanding queries and prevent delays in amendment implementation.

- Ensure adherence to SOPs, sponsor requirements, quality standards, and ICH-GCP principles.

- Maintain accurate study trackers, reports, and metrics for contract and amendment activities.

- Provide timely escalation of risks, delays, and operational challenges impacting study deliverables.

- Support audit readiness by maintaining complete and accurate documentation.

- Participate in process improvement initiatives and support departmental goals and objectives.

- Collaborate effectively with internal and external stakeholders to ensure efficient study execution.

- Complete assigned training, timesheets, and compliance-related activities within required timelines.

Requirements:

- University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex. Nursing certification, Medical or laboratory technology).

- 03-05 years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.

- Strong understanding of clinical trial contracting and protocol amendment processes.

- Knowledge of ICH-GCP guidelines and clinical research operations.

- Excellent communication, negotiation, and stakeholder management skills.

- Strong organizational and multitasking abilities with attention to detail.

- Ability to manage multiple studies and priorities within tight timelines.

- Proficiency in contract tracking systems and Microsoft Office applications.

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## Skills

### Required
- ICH-GCP guidelines
- clinical research operations
- contract tracking systems
- Microsoft Office applications
- communication
- negotiation
- stakeholder management

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Bangalore/REGULATORY-AND-START-UP_262931?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)
