Roshni Nasardeen

Experienced professional with focus on clinical research coordination. Capable of managing and overseeing clinical trials, ensuring compliance with regulatory standards and optimising workflow efficiencies. Utilises strong organisational skills and keen attention to detail to facilitate smooth project execution and enhance research outcomes.

Project Title: Anti Fungal Activity of Ethno Medicinal Plant (Pterocarpus marsupium), Main Duties, Assesses site qualification potential, Reviews study requirements; conducts pre-study visits and drafts pre-study evaluation reports., Participates in the implementation of clinical studies:, communicates with investigators and their staff; ensures compliance with terms and conditions; properly trains site personnel and writes initiation visit reports., Supervises the conduct of clinical studies:, acts as liaison between site personnel and the sponsor; performs monitoring in the field; ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports., Ensures the quality of the project:, verifies materials and data integrity; assists site personnel with internal audits or regulatory inspections; and perform ongoing follow-up with the in-house project team., Closes clinical studies:, Verifies the integrity of investigator files; ensures availability of clinical and non-clinical materials; jointly reviews with investigators the obligations inherent at the end of the study and writes closure visit reports.

• ICH-GCP training
• IATA training
• Paper CRF (Case Report Form)
• ECRF data entry (Inform , Oracle, Medidata Rave etc
• (e- Electronic CRF)
• IWRS data entry (Clinphone , UBC, Clarix etc)
• (Inter Web Response System)
• IVRS (Inter Voice Response System)
• Chromatography technique
• HPLC
• HPTLC
• GC
• UV spectrophotometer

• Internship in Clinisys Research- Bangalore diabetes centre(BDC), Bangalore(3 months) PHASE III -8 (Type II Diabetes Mellitus)
• PHASE IV -3 (Type II Diabetes Mellitus)
• PHASE II -1 (Cancer)

• Managing Clinical Trial
• Protocol and study documents reviewing.
• Attending Investigator Meetings
• Source Documentation and Maintenance of records.
• Compliance to Protocol and regulatory authorities.
• Subject Safety and Data Integrity
• Interacting with IRB/Ethics Committee
• Interacting with sponsors(pharma companies)
• Training and mentoring additional staffs
• Scheduling Principal Investigator's(Medical Doctor) visits with Monitor
• IP (Investigational Products) Dispensing and accountability
• IVRS/IWRS –data uploading
• Coordination with Monitors
• Patient counseling and recruitment
• Record keeping and Archival
• BA/BE study maintenance

• Internship in Clinisys Research- Bangalore diabetes center(BDC), Bangalore (3

months) PHASE III -8 (Type II Diabetes Mellitus)

• PHASE IV -3 (Type II Diabetes Mellitus)
• PHASE II -1 (Cancer)

I hereby solemnly affirm that all the details provided above are true to the best of my knowledge and belief and that at all times. I shall carry myself in a manner that lends dignity to the organization and worthy enough of the person. Place: Coimbatore Regards, Roshni.N