SUHAIL NASEEM
New Delhi
Summary
With 3+ years of experience in the clinical domain, I have excelled as a Monitoring Coordinator and Clinical Research Associate. My expertise spans diverse therapeutic areas such as ophthalmology, psychiatric hypertension, Covid19, diabetic ,real-world studies, respiratory and Dermatology and medical device research. This broad background has provided me with a deep understanding of the industry, enabling me to make valuable contributions to any clinical team.
Overview
5
5
years of professional experience
Work History
Clinical Research Associate-I
Cliantha Research
02.2023 - Current
- Conduct Monitoring visit to perform onsite review of files and records of document verification and review of case Report form for completeness, accuracy, consistency and protocol compliance.
- Perform drug accountability to ensure adequate storage, dispensing and use of investigation products at the site.
- Conduct the initiation visit to open Investigation sites for clinical studies and ensure the Investigation product has been received and ready for commencement of the study.
- Ensure Visit Reports are written and submitted via CTMS within 5 working days of visiting Educates and trains site and study staff in conduct and management of sponsored studies.
- Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.
- Liaising with doctors/consultants or investigators on conducting the trial.
- Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.
- Prepare and maintain ISF, TMF, study logs and any other study related documents.
- Subject/Patient recruitment at sites as per the expected target, in the allotted time.
- Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.
- Compliance to the project management plan with respect to all study execution related activities.
- Compliance with the monitoring plan, coordinating with study site and conducting site monitoring visits.
- Source data verification.
- Informing consent form review, case report form review, investigational drug accountability, and adverse event review.
- Safety reporting of serious adverse events at sites under purview to the sponsors and regulators as the applicable guidelines.
- Follow-up with sites and relay of information to Sr. CRA and Project Manager.
- Ensuring all unused trial supplies are accounted for.
- Writing visit reports, filing and collecting trial documentation and reports.
- Project Handled- USFDA & EU
Clinical Research Associate
Insignia Clinical Services Private Limited
06.2022 - 10.2022
- Be the first point of contact for any patient or site-related queries from investigators/site personnel for ongoing trials.
- Responsible for site relationships for the assigned sites.
- Effectively manage assigned clinical trial sites across one or more therapeutic areas.
- Prioritize work effectively and ensure all tasks are completed on time and with high quality, in accordance with company policies, ICH- GCP, and regulations.
- Effectively multi-task various site-related functions across all assigned sites such as feasibility, investigator selection, Monitoring, follow-up with the site for a trial update, collaborating with the site for patient recruitment strategies, safety reporting, etc.
- Validate the consistency between the source and data captured on the CRFs to ensure credible and quality data is generated from the site.
- Ensure subject eligibility for the clinical trial, Verifying clinical notes/source documents.
- Confirm correct informed consent process has been followed at the site.
- Perform Site Selection, Initiation, Monitoring, and Close-out visit as per Monitoring Plan and complete the visit report CRO SOP.
Clinical Research Associate
Worksure MedPharma Private Limited
01.2022 - 06.2022
- Assisting Senior CRA in Performing onsite visit.
- Follow up with the site and assisting site for the Queries missing pages SAE PD and medical queries.
- Taking the site update.
- Preparing the log for the SIV.
- Maintaining the ETMF and review the documents.
- Ensuring the TMF/ ETMF and site master files are updated all the time. Maintenance of trial related documents and files within the facilities.
- Performing Site Selection, Initiation, Monitoring, and Close-out visit as per Monitoring Plan.
- Completing the visit report CRO SOP.
- Projects Handled-Healthium and Ayush
- Phase 4 - Medical Devices (14 Studies)
- Phase 3 - Covid-19 (Gudichyadi)
Clinical Site Monitoring Coordinator / Clinical Site Coordinator
Innvocept Global Solution Private Limited
11.2020 - 01.2022
- Assisted in training/monitoring of subject data, enrollment, ICF, follow up of the subjects timely to the clinical site staff according to the protocol.
- Extending support to the PI/ Site staff in managing the documentation/CRF form's/CTMF/eTMF conducted in compliance to Good clinical practice (GCP).
- Regularly follow-up with the clinical sites & ensures that all activities are aligned according to the study protocol.
- Ensure subject safety, data quality & accurate study timelines & quality standards are met.
- Implementing appropriate activities to ensure that site meets the enrolment target on time within agreed timelines by enhancing the enrollment schedule.
- Looking after the progression of the subject enrollment in the site's and follow up of the subjects without any missing dates/ timelines according to the protocol.
- Maintaining quality of subject data/ CRF form's/Delegation logs/ICF/Site training log's/Subject screening log's/Safety report form's& Audit of the same.
- On time submission and completion of CRF/eTMF entry of the clinical sites/ Data query generation resolution in eTMF to CRO.
- Actioning plans by submitting regular site visit reports timely to CRO.
- Actioning plan by addressing issue/deviation or any violation in the clinical site/source documents/CTMS/eTMF to sponsor& CRO.
- Validating & entry of all the site subjects into eTRF. Updating& resolving the data queries regards to the eTMF.
- Ensuring that all the adverse events (AE's)/ serious adverse events (SAE's)/ product quality Complaints (PCQ's) Protocol violations are tracked, documented & reported properly within the clinical sites.
- Ensuring that the collected clinical data is available to PI/Sponsor& CRO.
- Projects Handled- Glenmark Project& Abbott Project and Semi -Sabina
- Ophthalmology: A phase 3 randomized double blind multi-center study to compare the efficacy and safety of topical timolol 0.5% in patients with ocular hypertension or open angle glaucoma.
- Diabetic: A Phase 4 Study Glenmark Project & Abbot Project
Clinical Research Associate
Cytespace researchprivatelimited
07.2020 - 09.2020
- Monitoring of subject data.
- Providing the subject report Doing the edc.
- EDC Handled- Openskies, INS, Vigi Data, Octa soft, Clinidox
Education
Advanced Diploma - Clinical Research
Apollo Hospital
New Delhi01.2020
B.Pharma - undefined
IIMT College of Medical Sciences
Meerut, U.P01.2019
Skills
- Clinical Trial Monitoring
- GCP (Good Clinical Practice) Compliance
- ICH Guidelines
- Site Initiation, Monitoring & Close-Out Visits
- Source Data Verification (SDV)
- Adverse Event (AE) & Serious Adverse Event (SAE) Reporting
- Informed Consent Process Review
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture (EDC) Systems (eg, Medidata, Oracle InForm)
- Trial Master File (TMF) Maintenance
- Protocol Deviation Identification & Reporting
- Investigator Meeting Participation
- Audit & Inspection Readiness
Timeline
Clinical Research Associate-I
Cliantha Research
02.2023 - Current
Clinical Research Associate
Insignia Clinical Services Private Limited
06.2022 - 10.2022
Clinical Research Associate
Worksure MedPharma Private Limited
01.2022 - 06.2022
Clinical Site Monitoring Coordinator / Clinical Site Coordinator
Innvocept Global Solution Private Limited
11.2020 - 01.2022
Clinical Research Associate
Cytespace researchprivatelimited
07.2020 - 09.2020
Advanced Diploma - Clinical Research
Apollo Hospital
B.Pharma - undefined
IIMT College of Medical Sciences
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