Headline

Quality Specialist-2 @ Clintask Solutions Pvt. Ltd | ICH, Research Skills

About

currently working as a clinical research coordinator i have worked for few projects.Screening and registration of subjects in the study participation management according to ethics, regulation, Institution SOP and protocol specific requirements. Documentation and assurance that the compliance process has already been completed. Accurate and timely data entry. Maintaining the regulatory study files for each research project Communicate with the IEC as appropriate. Ensuring proper maintenance and storage of investigational product (IP). Reporting serious adverse events (SAEs) to IEC, sponsor, CDSCO, Institutional heads and relevant regulatory authorities. Meeting with sponsor representatives for planning and discussing ongoing studies. Monitor study closure and reporting of results. Participate in audit preparation activities of sponsors, DCGI, FDA, other regulatory and accreditation agencies and regulatory affairs. Develop appropriate recruitment strategies and track study record. Other study activities according to the delegation log.

Location

Hyderabad

AI stack

anthropic apis

claude code

gemini

github copilot

hugging face

Work experience

Quality Specialist-2 at Clintask Solutions Pvt. Ltd, Jan 2026 - Present · 11 mos, India

Clinical Research Associate at Noah Therapeutics Pvt. Ltd., May 2024 - Jan 2026 · 1 yr 9 mos, Hyderabad, Telangana, India

Clinical Research Coordinator at Sri Sri Holistic Hospitals, Aug 2022 - Apr 2024 · 1 yr 9 mos, Hyderabad, Telangana, India

Education

Bachelor of Pharmacy - BPharm, Health/Health Care Administration/Management, Bharat Institute of Techonlogy

Postgraduate Degree, Pharmaceutical Regulatory Affairs, Princeton College of Pharmacy