Bijoy Joy

Experience

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  Apollo Hospitals Educational & Research Foundation, Hyderabad.

  Sept 2009 - Feb 2012

  Senior Clinical Research Co-ordinator

  • Oversee performance of clinical trial research projects to ensure compliance with ethical guidelines.• Coordinating the day-to-day activities of the research study team specifically engaged in carrying out the research clinical protocol.• Coordinating and actively recruits and formally consents study subjects for enrollment.• Preparing research study advertisements for submission to the institutional review board (IRB) for approval to aid in subject recruitment.• Performing input, retrieval, and analysis of data for processing and validation, and maintains research databases on excel.• Implement and monitor clinical trial to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and FDA and ICH guidelines.• Act as the liaison between the IRB Board and research staff about study related information• Conduct monitoring visits to confirm protocol compliance, assess qualifications of studypersonnel, ensure “Good Clinical Practice”, and conduct close-out visits• Verify data in source documents agree with source, initiate data query resolution and confirm resolution in timely manner.• Ensure subject safety and adverse event reporting to sponsor and IRB/IEC.• Prepares and distributes IRB meeting agenda, attend IRB meetings, take notes on the observations raised, maintain confidential research documents, submit IRB approval to the sponsors and arrange the financial payments to the IRB.• Verify drug accountability logs and storage requirements.• Respond to requests from investigative sites in a timely fashion and other study requirements. Show less

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  Covidien

  Jun 2012 - Apr 2013

  Regulatory Affairs Specialist/Officer

  • Contributes to the Indian regulatory submission process; may aid in authoring and/or publishing electronic submissions• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products• Evaluate risk of proposed regulatory strategies; may offer solutions• Reviews proposed labeling for compliance with applicable US and international regulations• Reviews proposed product changes for impact on regulatory status of the product• Oversee regulatory documentation including technical files, own brand agreements, product testing,and other related items.• Oversee the complaint system including complaint processing, assisting with the investigation,follow-up, close-out, and trending.• Prepare and/or assists with the submission and management of activities related to domestic andinternational registrations, certificate renewals, establishment registration and device listing, exportcertificates or FDA annual reporting. Show less

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  Bovian Healthcare

  May 2013 - Jun 2013

  Sr. Executive- Regulatory Affairs & Marketing

  Develop and execute regulatory plans for new registrations, drive labelling process, preparation and compilation of registration dossiers, create & submit federal licensing applications, provide guidance and feedback to regulatory affairs management.

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  Bio-Rad Laboratories

  Sept 2013 - Jan 2019

  Sr. Quality Management & Regulatory Affairs Specialist

  • Quality: Implementation and maintenance of Quality Management and Improvement system requirements (preparing quality documents & SOPs, monitor clinical process and outcomes, evaluate training needs, develop auditing, lead and oversee onsite audit process)• Regulatory: Manage the regulatory framework of the organization and ensure statutory compliance with the applicable regulations• Clinical Research: Plan and coordinate the initiation, monitoring and closure of clinical trial studies at sites. Ensure the study adherence to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Research practices (GRP), maintain research files and perform other clinical supports.• Interact and communicate effectively with the PI / Research Team at the site to ensure ethical conduct of the research according to the approved research protocol.• Train the staff on the study protocol and provide all the necessary administrative, financial and logistic support as and when required. Show less

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  Aaranya Management Services AMSPL

  Jan 2019 - now

  Quality Management Coordinator, Clinical Research & Regulatory Associate

  • Quality & Auditing: Implementation and maintenance of Quality Management and Improvement system requirements (preparing quality documents & SOPs, planning and conducting audits, training the clients on QMS requirements, control of documents, ensure non-conformances are properly reported and resolved, drive continuous improvement strategy and ensure customer requirements are satisfied)• Regulatory: Provide regulatory support and ensure compliance with statutory requirements.• Clinical Research: Remote monitoring of the trial sites as per the requirements of the study protocol.• Review all the clinical trial documents, verification that the investigator is enrolling only eligible subjects, source document & regulatory document review, assess the research site’s patient recruitment and retention success.• Responsible for the review of IRB submissions, update IRB policies and guidelines, prepare SOPs with different departments, maintain confidential documents and ensure the protection of human subjects. Provide regulatory support concerning the human research. Show less