Clinical Research Associate

Company Description

At Novaspire, we pride ourselves on being a trusted partner to the pharmaceutical industry, dedicated to delivering comprehensive, high-quality clinical research services. We specialize in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the drug/product development lifecycle, from clinical studies Phase I to post-market surveillance. Novaspire's core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services & training, and imaging studies. With over 75 years of combined experience, our team has guided companies through the complexities of GxP compliance by providing solutions and streamlining processes.

Role Description

·    Plan and conduct site feasibilities, site selection visits, site initiation visits, monitoring visits, close out visits across Pan India Novaspire clinical sites/hospitals.

·    Prepare and send the confirmation and respective site visit reports as per the SOPs.

·    Send the visit follow-up letters and coordinate on action items with respective clinical site teams.

·    Coordinate for the site-set up activities.

·    Ensure the site and trial master files are updated.

·    Coordinate with clinical site teams for prompt data entries, source data verifications, data entry errors, corrections and closure of data issues.

·    Oversee end-to-end processing of ICSRs (spontaneous, literature, clinical trial, and solicited reports).

·    Contribute to narrative writing and seriousness assessment.

·    Analyse and handle product complaints and medical inquiries with cross-functional collaboration.

·    Conduct regular and ad hoc literature surveillance for safety signals and case identification.

·    Ensure audit readiness and adherence to company SOPs and regulatory expectations.

·    Coordinate with clinical sites, investigators, and internal teams to ensure timely execution of study activities.

·    Prepare and review essential trial documents, including informed consent forms, study protocols, and investigator brochures. Manage and maintain Trial Master File (TMF) and ensure documentation is complete and audit-ready.

·    Track study progress, monitor site performance, and manage data collection timelines.

Prepare the SOPs related to PV/CT Department of Novaspire Biosciences as applicable.

Qualifications

• Clinical trial monitoring, regulatory compliance, and documentation skills
• Experience with site visits and coordinating with clinical trial sites
• Strong attention to detail and data quality management skills
• Excellent communication and collaboration skills
• Experience in the pharmaceutical or biotechnology industry is a plus
• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field
• Ability to work on-site in Bengaluru