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Rikana R

Senior Clinical Research Coordinator at Tamilnadu Government Multi Super Speciality Hospital, Chennai working with Leads Clinical Research and BIO Services Pvt.Ltd.- India

Chennai

2+ years of work experience

Mar 20251 yr 2 mosPresent

Leading and coordinating clinical trial activities across multiple therapeutic areas while ensuring compliance with ICH-GCP guidelines, IRB requirements, and regulatory standards. Responsible for overseeing study operations, participant management, and regulatory documentation to ensure high-quality data collection and smooth execution of clinical studies. Key Responsibilities • Coordinate and manage Phase I–IV clinical trials in collaboration with investigators, sponsors, and CROs. • Oversee patient screening, recruitment, informed consent, and follow-up visits. • Maintain and review regulatory documentation, source documents, and study files to ensure audit readiness. • Ensure accurate and timely data entry, verification, and reporting in clinical trial systems. • Monitor study progress and support protocol adherence across research teams. • Collaborate with multidisciplinary teams to ensure efficient trial execution and participant safety. • Provide operational support and guidance to junior research staff and coordinators.
Mar 20241 yrFeb 2025

Supported the execution of Phase III and Phase IV clinical trials at Tamil Nadu Government Multi Super Speciality Hospital, Chennai. Responsible for coordinating day-to-day clinical trial activities, managing patient interactions, and ensuring regulatory compliance throughout the study lifecycle. Key Responsibilities • Assisted investigators in conducting clinical trials in accordance with study protocols, ICH-GCP, and regulatory guidelines. • Screened and recruited study participants and obtained informed consent. • Collected patient medical histories, vital signs, and clinical data as required by study protocols. • Maintained regulatory documents, source records, and study files. • Performed data entry and verification to ensure accuracy and completeness of trial data. • Coordinated with investigators, sponsors, and hospital departments for smooth study operations. • Contributed to studies across multiple therapeutic areas including oncology, cardiology, neurology, and autoimmune diseases.

Education

Doctor of Philosophy - PhD, Biotechnology

Chettinad Academy of Research & Education, Kancheepuram

PHARM D [Doctor of Pharmacy]

Krishna Teja Pharmacy College, Tirupati

20176 yrs2023

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Headline

Senior Clinical Research Coordinator at Tamilnadu Government Multi Super Speciality Hospital, Chennai working with Leads Clinical Research and BIO Services Pvt.Ltd.- India

About

As a dedicated Clinical Research Coordinator with 2 years of experience in managing and supporting clinical trials, I am passionate about advancing medical knowledge and improving patient outcomes through ethical and efficient research practices. I’ve worked across phases I–IV studies in a variety of therapeutic areas, ensuring compliance with GCP, IRB guidelines, and FDA regulations. My role bridges science and patient care - I coordinate subject recruitment, maintain regulatory documentation, manage data collection, and collaborate closely with sponsors, investigators, and healthcare professionals to keep studies on track. What drives me most is knowing that the work I do today contributes to the treatments of tomorrow. I’m always looking to connect with professionals in clinical research, healthcare, and biotech who are equally committed to excellence and innovation in this field. Let’s connect and explore how we can make an impact together.

Location

Chennai

Work experience

Senior Clinical Research Coordinator at Leads Clinical Research and BIO Services - India, Mar 2025 - Present · 1 yr 2 mos, Leading and coordinating clinical trial activities across multiple therapeutic areas while ensuring compliance with ICH-GCP guidelines, IRB requirements, and regulatory standards. Responsible for overseeing study operations, participant management, and regulatory documentation to ensure high-quality data collection and smooth execution of clinical studies. Key Responsibilities • Coordinate and manage Phase I–IV clinical trials in collaboration with investigators, sponsors, and CROs. • Oversee patient screening, recruitment, informed consent, and follow-up visits. • Maintain and review regulatory documentation, source documents, and study files to ensure audit readiness. • Ensure accurate and timely data entry, verification, and reporting in clinical trial systems. • Monitor study progress and support protocol adherence across research teams. • Collaborate with multidisciplinary teams to ensure efficient trial execution and participant safety. • Provide operational support and guidance to junior research staff and coordinators.

Clinical Research Coordinator at Leads Clinical Research and BIO Services - India, Mar 2024 - Feb 2025 · 1 yr, Supported the execution of Phase III and Phase IV clinical trials at Tamil Nadu Government Multi Super Speciality Hospital, Chennai. Responsible for coordinating day-to-day clinical trial activities, managing patient interactions, and ensuring regulatory compliance throughout the study lifecycle. Key Responsibilities • Assisted investigators in conducting clinical trials in accordance with study protocols, ICH-GCP, and regulatory guidelines. • Screened and recruited study participants and obtained informed consent. • Collected patient medical histories, vital signs, and clinical data as required by study protocols. • Maintained regulatory documents, source records, and study files. • Performed data entry and verification to ensure accuracy and completeness of trial data. • Coordinated with investigators, sponsors, and hospital departments for smooth study operations. • Contributed to studies across multiple therapeutic areas including oncology, cardiology, neurology, and autoimmune diseases.

Education

Doctor of Philosophy - PhD, Biotechnology, Chettinad Academy of Research & Education, Kancheepuram

PHARM D [Doctor of Pharmacy], Krishna Teja Pharmacy College, Tirupati