Ethics Coordinator at Medanta Gurgaon

Role & responsibilities

• Manage the administrative review process of the Medanta Review Boards (MIEC/MIRB/ MSMC/IC-SCRT/DSMB)
• Coordinate and manage all aspects of the submission, review, revision, and approval of all research protocols
• Communicate and liaise effectively with investigators, research coordinators and government agencies
• Coordinate and support the review board activities and its members
• Maintain day to day review board documentation filing, storage and archival, in both electronic and hard-copy formats
• Review all the protocol submissions (new study dossiers, amendments, annual report, CSR, Close-out report etc.) to ensure that the submission is in compliance with the review board SOP and policies
• Review the reported SAEs and protocol deviations submitted for ethics committee review
• Support and sustain the quality of the ethical review by implementing quality control measures for document review
• Work independently, but under the supervision of the member secretary and the chairman of the review board(s)
• Actively work and assist the review board member secretary in all the review board related activities creation and revision of SOP and Policy of review boards; registration of review boards, creation and circulation of directives, sending responses to the drug regulator and day to day review board related activities
• Coordinate and attend review committee meetings, prepare meeting agendas and adequately capture MoM (Minutes of the meeting)
• Ensure that the ethical review for all research conducted at site is carried out efficiently and accurately according to national and international standards for ethical review
• Record medical and ethical issues discussed and ensure accurate documentation of final committee determinations

• Compose clear, concise and detailed correspondence to principal investigators to ensure that committee concerns, questions and rationale are appropriately communicated to researchers
• Evaluate investigator responses to determine if they are adequate or if additional information is needed
• Manage day-to-day administrative coordination between investigators, research staff and research reviewers
• Monitor regulated clinical trials to ensure procedures for ethical review are implemented effectively and efficiently
• Keep research operations team timely updated about review board recommendations, changes in review board composition, SOP and Policies, new directives etc.
• Manage and maintain the EC finance & budget.

Preferred candidate profile

• At least 1 year experience as a Trainee or Research Coordinator
• Experience in a research and/or regulatory environment
• Should be thorough with the ethical standards, research guidelines and regulations
• Competence in Basic Computer skills (MS office and internet)
• Medical/Para-medical/Life Sciences background
• Post Graduate Degree/Diploma/Experience of minimum 1 yr. in Clinical Research

Interested candidate can share CVs at neha.bhatnagar@medanta.org