Clinical Trial Associate
Clinical Trial Associate
Fortrea
Job description
Ready for the next step in your clinical research and study coordinating career? Check out the Centralized Study Spec II job at Fortrea in Bengaluru, India.
Company Description
Fortrea is a global contract research organization (CRO) that partners with pharmaceutical, biotechnology and medical device firms to advance clinical development. It provides clinical trial services and research operations to support customers in the development of medical treatments and the delivery of innovative therapies to patients. The company promotes collaboration, quality and operational excellence throughout clinical research programs.
Job Summary
This is a full-time post headquartered in Bengaluru . It is for management of clinical trial contracts and revisions for ongoing clinical research studies. The Clinical Trial Coordinator will handle the preparation and negotiation of site agreements, coordinate approval processes, track contract timelines, and maintain correct records. The position involves working with sponsors, clinical operations, legal, regulatory and finance teams and ensures that clinical research activities are conducted in accordance with defined processes, quality standards, and ICH-GCP recommendations.
Key Responsibilities
Prepare, review, negotiate and execute Clinical Trial Agreements (CTAs), confidentiality agreements, contract revisions and other site relevant contractual papers.
Work with sponsors, legal, clinical operations and study teams to ensure timely approval and signing of contracts
Monitor timelines of site agreement activities and ensure contract activities are in alignment with study milestones and agreed turn-around times.
Update the contract status and keep documentation in the systems e.g. SAMS, UCV and other applicable systems.
Coordinate internal evaluations, get appropriate approvals and monitor execution and filing of executed agreements.
Identify potential contractual delays, risks and operational obstacles and escalate severe issues to management where appropriate.
Advise study teams and management of research progress, pending approvals and outstanding concerns.
Coordinate submissions of protocol amendments and update pertinent study documents for assigned sites.
Support authorized protocol updates that roll over to contracts and budgets.
Educate research teams and clinical sites about amendment requirements, paperwork needs and schedules.
Track amendment progress to help guarantee timely submission, approvals and implementation.
Coordinate associated actions with Clinical Operations, Regulatory, Legal and Finance departments.
Educational Qualification
A Bachelor's degree in Life Sciences from an accredited university is preferred.
Candidates with a qualifying degree in an allied health profession (e.g. nursing, medical technology or laboratory technology) may also be considered.
Skills Required
Good working knowledge of clinical trial agreements and site contracting processes.
Familiarity with protocol amendment processes and documentation.
Knowledge of ICH-GCP guidelines and clinical research procedures.
Negotiation of contracts and coordination of stakeholder skills.
Good organizational abilities and close attention to detail.
Experience with contract tracking systems such as SAMS and UCV, if appropriate.
Knowledge of Microsoft Office software.
Can recognize possible delays, communicate problems and escalate risks as required.
Excellent paperwork and record-keeping skills.
Ability to work cross-functionally with internal departments, sponsors and clinical research sites.
Salary Structure
The average salary of a Clinical Trial Associate in India is ₹8–12 lakhs per year.
Career Development
The position, as a Clinical Trial Coordinator, offers an opportunity for individuals to further develop their skills in areas that include clinical trial contracts, protocol revisions, regulatory compliance and study coordination. Working with cross functional clinical research teams also provides possibilities to develop skills in negotiating, stakeholder management and documentation.
How to Apply
Search for Clinical Trial Associate role on our job portal.
Click on the job post for the details.
Fill in the information and upload your updated resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
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