Shamnun Muhebb (Ovee) MS,M.B.B.S,ACRP-CP,ACRP-PM

Experience

• 

  Apollo Hospitals

  Oct 2014 - Mar 2015

  Resident Medical Officer
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  Next Space Limited

  Jan 2016 - Jul 2017

  House medic officer
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  United Hospital Ltd

  Aug 2016 - May 2018

  Senior Medical Officer
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  Impulse Hospital

  Aug 2018 - Jun 2019

  Senior Medical Officer(Nephorology Department)and In-charge of Dialysis Department
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  DM Clinical Research

  Nov 2020 - Jan 2024

  Monitoring and evaluating in accordance with current quality and compliance standards, along with regulatory and clinical trial trends/actions, with regular reports to QA management.Maintaining a working knowledge of FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents and study protocols.Reporting project status and issues to management on a regular basisMeeting with the clinic team and Principal Investigators to discuss quality/compliance trends.Partnering with study teams to identify potential changes and opportunities for process improvement pertaining to SOPs, guidance documents, and other documents, as needed.Educating and mentoring research team with interpretation of regulatory requirements (e.g., GCPs), SOP requirements, and other guidance documents, as applicable.Evaluating responses to monitoring and audit reports with the research team; follow-up with applicable stakeholders to ensure resolution.Functions within study teams to conduct ongoing quality assurance reviews of clinical research studies, with the goal of assessing site readiness and develop site specific education and processes. Show less Compound and dispense prescribed IP.Supervise and maintain records of all medications.Ensure compliance to study specific blinding plans.Provide consultative support regarding preparation and dosing of drug.Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction.Interpret clinic schedule and protocol into a resource that can be used to identify date/times to compound/prepare and dispense IP for clinical trials.Understand and apply all applicable site procedures.Ensure receipt and proper storage of IP and bioretention samples.Manage inventory, ensuring that expired items are removed from inventory prior to expiration, and purchasing, and delivery processes for the pharmacy.Review protocols and provide input on clinical and pharmacy supply needs.Meet with sponsors, monitors, auditors, regulatory authorities to review drug accountability and other study specific information.Temperature Reporting. Show less

  • Quality Assurance Lead

    Dec 2023 - Jan 2024

  • QA Associate

    Dec 2022 - Jan 2024

  • Lead CRC

    Jan 2022 - Dec 2022

  • Clinical Research Coordinator

    Jul 2021 - Jan 2022

  • Clinical Trial Screening Coordinator

    Nov 2020 - Jul 2021
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  Vital Heart & Vein

  Jan 2024 - now

  Research Director

  Directly oversee site staff and manage staffing needs (interviews, training, performance reviews, etc)Mentor and support direct reports in their responsibilities and functions.Develop and refine subject visit flow and subject binders to ensure on time data capture by properly delegated staff for each subject visitManage and track vital trial metrics and operational objectives for the trial are in conformance to all relevant laws, regulations, GCP guidelines, protocol, and internal SOPs/policies.Study start up, ensure all protocol requirements are met, ordering of proper supplies, development of vendor relationships, coordinate staffing and proper coverageDistribute studies among coordinators, considering the site, coordinator, subject, experience, training & sponsor needs.Participate in the conduct of PSSVs, SIVs and introduce self to all CROs, Project Managers, CRAsProvide back-up for appropriate study tasks, as dictated by patient flow and staff coverageMaintain oversight of accurate and efficient data entry into all systemsAddress all patient, vendor, and sponsor complaintsFacilitate the Quality Control processManage budget and have an understanding of site financials. Show less