Regulatory Project Assistant - Clinical Trials (Entry-level)

Indero
Full Time • Remote
₹3 Lakhs - ₹6 Lakhs
India
Posted 3d ago

Regulatory Project Assistant - Clinical Trials (Entry-level)

Indero

Job description

Indero is hiring an entry-level Regulatory Project Assistant for a home-based role in India, offering a great career start in regulatory affairs and clinical trial documents.

Company Description  

Indero, formerly known as Innovaderm, is a clinical research company that specializes in dermatology and rheumatology. It has more than 25 years of experience and offers full-service trial support, from protocol design to monitoring. Indero works across North America, Europe, Asia Pacific, and Latin America. Its values are collaboration, innovation, reliability, and responsiveness.

Job Summary  

This is a permanent, full-time, home-based role for an entry-level Regulatory Project Assistant in India. The person will give admin support to the regulatory team and help with eTMF work. The role also covers uploading documents to the EU Clinical Trial Information System, called CTIS, and keeping submission tracking up to date. Some evening meetings are needed.

 Key Responsibilities 

  • Upload and keep documents in the CTIS EMA portal for first applications, changes, and notices, and track timelines.

  • File CTIS documents into the eTMF.

  • Prepare redacted versions of selected documents for CTIS submission.

  • Prepare ethics board documents for eTMF filing, such as approval letters and messages.

  • Support user requests and site setup for ethics board portals.

  • Help check eTMF user access lists against the staff list on a regular basis.

  • Prepare study documents for ethics and regulatory submissions.

  • Keep regulatory trackers up to date for assigned studies.

  • Check and track vendor invoices for ethics services.

  • Put together and format Clinical Study Reports and appendices for electronic submission.

  • Help set up, keep, and review the eTMF.

  • Help track project work and prepare status reports.

 Educational Qualification 

  • A degree in life sciences, pharmacy, or a related field is a good fit.

  • Experience in an admin support role is required, and experience in biotech, pharma, or a CRO is a plus.

 Skills Required 

  • Good written and spoken English.

  • Knowledge of the EU Clinical Trial Regulation and the CTIS business role.

  • Proficiency in Microsoft Word, Excel, and Outlook.

  • Good use of PDF editing software.

  • Strong organizational skills and ability to meet deadlines.

 Salary Structure 

The average annual salary of the Regulatory Project Assistant role at Indero typically ranges from ₹3 Lakh to ₹6 Lakh per annum.

 Career Development 

This position provides a beginning in regulatory and scientific areas at a company that is growing quickly in the clinical research field. It also includes learning and growth opportunities that can allow you to progress into jobs, in regulatory affairs or clinical operations.

How to Apply 

  • Visit our job portal and search for the Regulatory Project Assistant role at Indero.

  • Click on the job posting to see all the details about the job.

  • Enter your information and add your resume.

  • Send your application.

Employment Type: Full Time • Remote
Industry: Healthcare
Role Category: Clinical Research
Application: External (Company Site)

Education

Bachelor's Degree

Key Skills

Clinical ResearchNon Clinical Jobs

Market insights & trends

Salary Insights

The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.

Hiring Trends

The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.

Frequently Asked Questions

Everything you need to know about the process

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