ImmunoACT Clinical Trial Assistant Job For MSc Candidates, Apply Now!
ImmunoACT Clinical Trial Assistant Job For MSc Candidates, Apply Now! BSc, MSc Clinical Research job opening at ImmunoACT. ImmunoACT Clinical Research job opening. Interested and eligible applicants can check out all of the details on the same below
Job Title: Clinical Trial Assistant
Function: Clinical Trial and Regulatory Affairs
Report to: Project Manager
Location: MIDC Rabale, Navi Mumbai
Position Type: Full Time
About Immunoadoptive Cell Therapy Private Limited.
ImmunoACT was incubated in IIT Bombay in 2018 and is doing cutting edge work in the space of cell and gene therapy to treat various diseases including cancer, auto immune disorders.
It has set up a state-of-the-art GMP facility in Mumbai to scale its production and commercialize its patented product CAR T for lymphoma and leukemia treatment and a robust product pipeline.
ImmunoACT’s Strategic Investor partner, Laurus Labs Limited is a leading Indian pharma company headquartered in Hyderabad with global presence and is listed on the Indian stock exchange with market cap of ~USD 3 Bn.
To be a Leader in Cell & Gene Therapy for Patients’ Long-Term Cure through Translational Research in India & beyond
- Accessible and affordable to all
- Cutting edge research
- Transforming ideas to reality
Roles and Responsibilities
❖ Assist PM, CRA in trial related activities and coordinate with various teams.
❖ Follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried
out in accordance with state and federal regulations, guidelines, and policies.
❖ Prepare and procure documents for clinical dossiers for EC and Regulatory submission within timelines.
❖ Ensure that the site has the required study documents for the study conduct.
❖ Prepare SIV packages within timelines.
❖ Follow up with the CRCs/ sites for all the pending documents from the site on timely basis.
❖ Maintaining and updating in-house project files, core files and site files for completeness and correctness
❖ Study specific logs/forms, and project tracking tools.
❖ Preparation of minutes of meeting (visits/calls and Internal meetings).
❖ Maintaining Attendance records for all the meetings and training conducted for the study.
❖ Supply Management (Ancillary supplies / Drug/ Devices/ Documents)
❖ Procurement, storage, maintaining temperature of drug, importation of drug, and dispatch of study documents and
Supplies to sites/hospital as and when required.
❖ Coordination with the courier agency during shipment of supplies and drugs to sites.
❖ Maintaining inventory of all the supplies, updating logs and trackers.
❖ Support for Study Initiation (Documents and others)
❖ Support the site for site related requirements (Blank ICF, CRF, Labels, Box files etc)
❖ Real Time Data Monitoring
❖ Maintain Study Tracker
❖ Assist in Tracking Site Payment
Qualifications and Educational Requirements:
❖ Bachelor’s degree in Science, or relevant field.
❖ Diploma/ MSc in Clinical research.
❖ 1 to 2 years of experience in clinical research field.
❖ Good Organizing skills
❖ Well versed with Microsoft excel, word, power point
❖ Well versed with the Indian Regulations and Guidelines for the conduct of clinical trials
❖ Act as a central contact for the team for assigned project communications, correspondence and associated documentation
❖ Support the preparation, handling, distribution, filing, and archiving of clinical documentation and reports
❖ Ensure high levels of accuracy when completing tasks, you will set up, manage and maintain clinical study documentation and coordinate the ordering, dispatch and tracking of study materials.
Compensation: Compensation and other perquisites would not be a constraint for the right candidate
How to Apply – Email Id: Interested candidates can share their CVs to [email protected].
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