Jul 2018
Present
Clinical Research Coordinator
Sujata Birla Hospital And Medical Research Centre
Nashik, IN
Remidi Clinical Research Services
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines.
- Assist to Pl in lnformed Consent Procedure and involved in Screening Procedure, recruitment, enrollment.
- Performed source documentation and completed electronic case report forms (eCRFs) and performs query resolution in a timely manner.
- Monitored data expeditiously to reduce data discrepancies
- Oversees drug accountability and safety at sites.
- I have worked on Rave database and on other electronic database such as Inform, ERT, Clinion and have done clinical studies which comes under Clinical data Management.
- Maintain Study documentation in accordance with the sponsor protocol, SOPs, GCPs, ICH Guidelines and FDA regulations
- Reviewed essential/regulatory documents, ensuring Investigator Site Files (ISF) are accurate.
- Assisted in on-site monitoring of clinical trials including review of source documentation, case report forms, regulatory materials and drug accountability.
- Reviewed follow-up reports and implemented corrective action as needed
- Appropriately resolves issues related to trial monitoring.
- Reviewed lab reports and clinical data; contacted PI and discussed laboratory results and actions necessary to ensure protocol consistency and patient safety.
- Handling AE/SAE reconciliation. Track PD, AE, SAE and study material at site.
- Communication with CRA, Subjects, Central Lab, Local Lab, IVRS, IWRS and ancillary services related to protocol and site.
- Communication with Ethics Committee regarding submissions, notification, queries and approvals related to protocols.
- Attended Site initiation visits, on-site monitoring visits and site closure visits of all phases of clinical trials.
PERSONAL PROJECTS
- Study on Psoriasis Phase III(2018)
- Study on OLP Phase III (2018)
- Study on Soft Tissue Injury, Phase III (2018)
- Study on Acne, Phase IV(2018-2019)
- Study on Rheumatoid Arthritis, Phase III(2019)
- Study on Chronic Spontaneous Urticaria, Phase III (2018 - Present)
- Study on Diabetic Foot Ulcer, Phase III (2019 - Present)
- Study on Rheumatoid Arthritis, Phase III (2019 - Present)
- Study on Rheumatoid Arthritis, Phase III (2020 - Present)
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