Arpita Mohan Naik
Clinical Research Coordinator Senior Project Assistant @Father Muller Medical College Hospital
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WORK HISTORY
Clinical Research Coordinator Senior Project Assistant @Father Muller Medical College Hospital
Mangaluru, IN
Managed subject screening, informed consent, source documentation, eCRF entry, and query resolution• Coordinated sponsor and CRO monitoring visits and maintained regulatory documentation• Mentored junior CRCs based on performance excellence• Handled multiple concurrent studies ensuring protocol adherence and data qualityKey Studies:Ongoing: ICRAG-2 ENABLE (ICMR) – Phase Epilepsy (Ergomed)Phase I Alopecia Areata (Cliantha)Completed:Cancer Registry (ICMR)Phase IV Hepatocellular Carcinoma (SIRO)Phase IV Psoriasis (Eli Lilly)
EDUCATION
Maharanis Science College for Women India
Bachelors Degree, Biotechnology
Icri India
Msc, Clinical Research
ABOUT ARPITA MOHAN NAIK
Clinical Research Coordinator with over 3 years of experience in hospital-based clinical trials at Father Muller Medical College Hospital, Mangalore.Experienced across Phase I–IV clinical trials in dermatology, neurology, oncology, and registry-based research. Strong knowledge of ICH-GCP E6 (R2), informed consent process, subject screening, protocol adherence, source documentation, eCRF review, and coordination with sponsors and CROs.Currently involved in coordinating multiple concurrent studies while ensuring regulatory compliance, data quality, and timely execution of trial activities.Core competencies include:• Subject screening, enrollment, and informed consent• eCRF entry, CRF review, and query resolution• AE/SAE documentation and reporting• Sponsor and CRO coordination• Monitoring visit support and regulatory documentation• ISF and TMF maintenance• EDC systems: REDCap, iWRS, Zelta, AgcaptureTherapeutic areas & studies:• Phase Epilepsy (ICMR – Ergomed)• Phase I Alopecia Areata (Cliantha)• Phase IV Hepatocellular Carcinoma (SIRO)• Phase IV Psoriasis (Eli Lilly)• Cancer Registry (ICMR)• Phase Tinea Corporis• Phase NSCLC & Type 2 Diabetes MellitusActively seeking opportunities to transition into a Clinical Research Associate (CRA / CRA I) role.
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