Clinical Trial Associate (Bangalore) Vacancies | Sitero – Apply Now

Sitero, a leading provider of clinical services and software solutions in the life sciences industry, is currently seeking qualified candidates for the position of Clinical Trial Associate in Bangalore. This role is ideal for professionals with a Bachelor’s or Master’s degree in Life Science and at least 2 years of experience in the CRO or Pharmaceutical industry. 

About Sitero

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders acrossthe clinical research community with an emphasis on ethics, compliance, and innovation.

Job Overview

Position: Clinical Trial Associate
Location: Bangalore, Karnataka (Hybrid Model)
Function: Clinical Services

As a Clinical Trial Associate, you will provide high-quality assistance in managing and overseeing clinical trials. Your role will be crucial in ensuring that trials are conducted in accordance with ICH GCP and applicable guidelines, company and sponsor SOPs, and local regulatory requirements. You will also support Clinical Trial Managers on project-related activities and deliverables, including contracts, budgets, and document management.

Key Responsibilities

• Provides high quality assistance in managing and overseeing clinical trials in accordance with ICH GCP and applicable guidelines, company and sponsor SOPs, project plan, study-specific processes, and local regulatory requirements.
• Support Clinical Trial Managers on project related activities and deliverables as required which may include contracts and budget activities.
• Completes essential document collection and review throughout the study lifecycle, organizes and maintains site clinical trial master file (TMF) documents, and maintains site-related data in applicable clinical systems according to procedures and guidelines for record retention.
• Perform ICF customization in accordance with applicable guidelines and local regulatory requirements.
• Support the setup, data entry, and QC of the system to ensure accuracy and quality of data.
• Support submission of new trials to include updating protocols to the IRBs.
• Support study data as the EDC administrator while assisting with site monitoring via EDC and EDX applications.
• Support site CRAs with CTMS data entry and follow-up activities with investigator sites on pending actions, as needed.
• Compilation of Site File Documents per project specifications.
• Coordinate with printing vendor for preparation of Site Files, perform Site File QC and assist with dispatch of files to investigator sites in APAC region.
• Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
• Coordinate with other departments within the company, such as research and development, marketing, and accounting, to ensure that all aspects of a study are carried out successfully.

Required Qualifications

Preferred Skills

• Proficiency in IT tools such as Microsoft 365, Medidata, and CTMS.
• Strong written and verbal communication skills.

Compensation & Benefits

Sitero offers a competitive salary along with a comprehensive benefits package, including variable pay, paid time off, and healthcare and retirement benefits.

Employment Type

• Full-Time, Permanent
• Standard Hours: 40 hours per week, Monday – Friday. Additional hours as needed.
• Willingness to work in shifts when necessary.

How to Apply

Apply online through the Sitero career portal: Apply Here.

Tagged as: Good Clinical Practice (GCP)