Study Start-up Associate [Site Activation Specialist]
Study Start-up Associate [Site Activation Specialist]
Fortrea
Job description
Looking to build a career in clinical trial site activation and regulatory coordination? Explore this Study Start up Associate, Site Activation Specialist role at Fortrea in Bangalore.
Company Description
Fortrea is a global clinical research company focused on advancing life saving therapies for patients everywhere. The company believes in turning the impossible into possible through teamwork and shared commitment. Fortrea supports clinical trials and drug development through strong scientific expertise and reliable service. With a culture built on collaboration, the company continues to break barriers in modern clinical research.
Job Summary
This role acts as the primary contact for investigative sites during study start up and maintenance activities. As a Study Start-up Associate, you will collect required documents and coordinate submissions to ethics committees and regulatory authorities. You will ensure timelines and documentation meet sponsor and regulatory expectations. The role also involves guiding sites, mentoring newer colleagues, and staying updated on local regulatory requirements.
Key Responsibilities
Stay updated on regulatory rules and practices in assigned countries.
Coordinate and organize documents required by ethics committees and regulatory authorities.
Prepare and compile routine submissions, including applications and cover letters.
Liaise with internal teams and external vendors to support regulatory submissions.
Review final submission documents before they are sent for approval.
Keep start up and maintenance activities on track and within budget.
Follow ICH GCP guidelines, SOPs, and applicable quality standards.
Escalate study issues early and clearly, when needed.
Act as the main contact for investigative sites during start up.
Collect and track required documents, ensuring accurate formatting and compilation.
Keep documentation audit ready at all times.
Take part in team and project meetings as required.
Support site activation strategy and provide accurate timelines to study teams.
Review and adjust informed consent forms to meet local requirements.
Help resolve informed consent issues raised by study sites.
Support site contract and budget discussions, when applicable.
Flag risks to submission leads to help protect project timelines.
Support CTIS related tasks for centralized submissions across the EU.
Educational Qualification
University or college degree, preferably in life sciences, or a certification in a related allied health profession, such as nursing or lab technology.
Candidates with a High School Diploma and relevant experience may also be considered.
Skills Required
At least 2 years of experience in clinical research, start-up, or regulatory processes.
Strong working knowledge of ICH guidelines and IRB or IEC regulations.
Familiarity with investigator start-up documents and contract or budget negotiations.
Experience working with operational project teams and investigative sites.
Strong understanding of research protocol requirements.
Good communication skills, with the ability to explain protocol requirements clearly.
Salary Structure
The estimated salary for a Study Start-up Associate (Site Activation Specialist) at Fortrea in India ranges from ₹5 Lakhs to ₹9 Lakhs per year.
Career Development
This role offers hands on exposure to global site activation and regulatory coordination within a respected clinical research organization. Fortrea also supports long term growth through mentorship opportunities and a strong, collaborative team culture.
How to Apply
Visit our job portal and search for the Study Start up Associate, Site Activation Specialist role - Fortrea.
Click on the job listing to read all the details, about the job.
Fill in your information. Upload your resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
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