Fortrea is hiring for the position of Study Start-up Associate (Site Activation Specialist) in Bangalore and Mumbai. This is a full-time remote opportunity for professionals with experience in clinical development, clinical research, regulatory submissions, and site start-up activities.

The role focuses on coordinating investigative sites, collecting essential documents, supporting IRB/IEC, Ethics Committee and Regulatory Authority submissions, and ensuring sites are activated within agreed timelines and applicable regulatory requirements.

Candidates with a life-science degree and at least 2 years of relevant clinical research or regulatory experience can apply.

Fortrea Study Start-up Associate – Job Highlights

What Does a Study Start-up Associate Do?

A Study Start-up Associate is responsible for helping clinical trials move from study initiation toward site activation. The professional acts as an important point of contact between investigative sites, sponsors, regulatory authorities, ethics committees and internal clinical operations teams.

The role requires strong knowledge of ICH/GCP guidelines, regulatory requirements, IRB/IEC processes, essential documents and clinical trial submissions.

Key Responsibilities

The selected candidate will be responsible for:

• Coordinating with investigative sites during study start-up and maintenance activities.
• Collecting and tracking investigator and essential study documents.
• Preparing documentation required for EC/IRB/IEC and Regulatory Authority submissions.
• Preparing country application forms, cover letters and other submission documents.
• Compiling routine regulatory submissions, including INDs and CTAs, where applicable.
• Liaising with Regulatory Authorities and ethics committees regarding submissions and approvals.
• Coordinating with internal teams and external vendors involved in regulatory submissions.
• Reviewing final submission documents for completeness and quality.
• Ensuring study start-up activities remain aligned with timelines, budgets, SOPs and applicable regulations.
• Identifying, preventing and escalating study-related issues.
• Performing quality reviews, formatting and compilation of site activation documents.
• Ensuring study documentation is appropriately filed and clinical systems are updated.
• Supporting site activation strategy and providing timelines and projections.
• Reviewing and customizing country- and site-specific Patient Informed Consent Forms (PICFs).
• Supporting site contract and budget negotiations when required.
• Tracking contract and budget milestones.
• Identifying risks that could affect submission timelines and escalating them appropriately.
• Supporting Clinical Trials Information System (CTIS) activities for applicable EU studies.
• Uploading submission documentation to CTIS and monitoring notifications and alerts.
• Participating in project and team meetings.
• Mentoring and training less-experienced team members when required.

Fortrea Study Start-up Associate Qualifications

Applicants should meet the following minimum requirements:

• University or college degree, preferably in Life Sciences.
• Relevant allied health certification may also be considered.
• Minimum 2 years of experience in clinical research, clinical development, site start-up or regulatory processes.
• Strong working knowledge of ICH guidelines.
• Understanding of Regulatory Authority and IRB/IEC requirements.
• Familiarity with investigator start-up documentation.
• Knowledge of site contract and budget negotiation processes is desirable.
• Experience interacting with investigative sites and operational project teams.
• Ability to understand clinical research protocols and communicate requirements effectively.

Fortrea may consider relevant equivalent experience in place of educational requirements. Candidates with a high school diploma/equivalent and at least two years of relevant clinical research experience may also be considered.

Suitable Degrees

Relevant educational backgrounds can include:

B.Pharm, M.Pharm, Pharm.D, B.Sc, M.Sc, Biotechnology, Microbiology, Biochemistry, Life Sciences, Nursing, Medical Laboratory Technology, Allied Health Sciences, or related disciplines.

The job description states that a life-science degree is preferred, rather than restricting the position to one specific degree.

Skills Required

Candidates looking for Study Start-up Associate jobs in India should ideally have skills in:

• Clinical Research
• Clinical Trial Start-up
• Site Activation
• Regulatory Affairs
• ICH-GCP
• IRB/IEC Submissions
• Ethics Committee Submissions
• Regulatory Authority Submissions
• Essential Document Management
• Investigator Site Management
• CTIS
• Clinical Trial Documentation
• Informed Consent Forms
• Clinical Development
• Contract and Budget Coordination
• Regulatory Compliance
• SOP Compliance
• Risk Identification and Escalation

Salary and Benefits

The supplied Fortrea job description does not specify a salary or detailed employee benefits package for this position.

For informational purposes, a reasonable market estimate for a Study Start-up/Clinical Trial Start-up professional with around 2+ years of relevant experience in India could be approximately ₹5 lakh–₹9 lakh per annum, depending on experience, location, skills and compensation structure. This is an estimate and not an officially advertised Fortrea salary.

Candidates should confirm compensation and benefits directly through the official recruitment process.

Work Location

This is listed as a Remote, full-time position with locations in:

• Bangalore, Karnataka
• Mumbai, Maharashtra

How to Apply

Application Link