Role Overview: The Clinical Research Documentation Specialist supporting the Head of the Ethics Committee (EC) Division plays a key role in ensuring all documentation is accurate, compliant, and audit-ready. This position requires managing end-to-end responsibilities related to clinical research documentation in alignment with regulatory, institutional, and ethical guidelines. End-to-End Responsibilities: Regulatory Document Management: Maintain essential trial documents as per ICH-GCP guidelines. Prepare and update Investigator Site Files (ISFs) and Trial Master Files (TMFs). Ensure timely submission of study protocols, amendments, and informed consent forms to the Ethics Committee. Ethics Committee Coordination: Assist in the preparation of EC meeting agendas, presentations, and minutes. Track and manage EC approvals, re-approvals, and continuing reviews. Ensure documentation of decisions and communications is accurate and up to date. Protocol & SOP Compliance: Ensure study-related activities align with standard operating procedures (SOPs), protocols, and regulatory requirements. Prepare documentation to demonstrate compliance during audits or inspections. Communication and Liaison: Act as a bridge between the clinical research team and the EC. Coordinate with investigators, sponsors, and regulatory bodies for documentation needs. Audit & Inspection Readiness: Support internal and external audits by providing required documentation. Implement corrective and preventive actions (CAPA) as per audit findings. Training & Documentation Support: Provide training on documentation practices and GCP compliance. Assist in drafting SOPs related to documentation and EC processes. Archival & Record Management: Manage secure archival of all EC and trial-related documents. Ensure document retention policies are followed. Job Type: Full-time Pay: ₹18,000.00 - ₹22,000.00 per month Benefits: Health insurance Provident Fund Schedule: Day shift Rotational shift Supplemental Pay: Joining bonus Overtime pay Performance bonus Yearly bonus Work Location: In person

Administrative Support: Coordinate schedules, meetings, and appointments for clinical, regulatory, or ethics teams. Maintain office supplies, facility upkeep, and vendor management. Ensure smooth onboarding and documentation for new staff. 2zDocument & Record Management: Maintain Trial Master File (TMF) , essential documents, and regulatory binders. Assist in document control: version control, filing, scanning, and storage. Manage SOPs , training records, contracts, and correspondence. Support to Clinical Teams: Assist Clinical Research Associates (CRAs), Coordinators, and Investigators with site logistics. Arrange travel and accommodation for monitoring visits or investigator meetings. Track and follow up on site payments and agreements. Compliance & Audit Support: Assist in preparing for audits (internal/external/ethics/Regulatory). Ensure documents are audit-ready and properly archived. Follow GCP, ICH, and organizational SOPs. Communication & Coordination: Act as a liaison between departments – clinical, regulatory, IT, HR, and finance. Coordinate ethics committee submissions and meeting logistics. Follow-up with vendors, clients, and sponsor representatives. Data Entry & Report Generation: Enter study-related information into clinical systems or spreadsheets. Support tracking of study progress, adverse events, and document status. Facility & IT Support Coordination: Coordinate with IT for user accounts, system access, and hardware needs. Maintain access logs, security camera records (if part of responsibilities). HR & Staff Coordination Support Assist HR in scheduling interviews, onboarding/offboarding tasks. Maintain attendance, leave records, and update trackers. Help with ID cards, asset allocation forms, and induction documents. Finance/Admin Assistance Assist in processing invoices, bills, and petty cash records. Regulatory & Compliance Support (If in CRO) Support teams in preparing ethics committee submissions or regulatory file copies. Assist in formatting/stamping/printing of clinical study documents. Maintain vendor file updates and follow-up on payments if needed. Job Type: Full-time Pay: Up to ₹375,000.00 per year Benefits: Health insurance Provident Fund Schedule: Day shift Rotational shift Weekend availability Supplemental Pay: Yearly bonus Work Location: In person

Administrative Support: Coordinate schedules, meetings, and appointments for clinical, regulatory, or ethics teams. Maintain office supplies, facility upkeep, and vendor management. Ensure smooth onboarding and documentation for new staff. 2zDocument & Record Management: Maintain Trial Master File (TMF) , essential documents, and regulatory binders. Assist in document control: version control, filing, scanning, and storage. Manage SOPs , training records, contracts, and correspondence. Support to Clinical Teams: Assist Clinical Research Associates (CRAs), Coordinators, and Investigators with site logistics. Arrange travel and accommodation for monitoring visits or investigator meetings. Track and follow up on site payments and agreements. Compliance & Audit Support: Assist in preparing for audits (internal/external/ethics/Regulatory). Ensure documents are audit-ready and properly archived. Follow GCP, ICH, and organizational SOPs. Communication & Coordination: Act as a liaison between departments – clinical, regulatory, IT, HR, and finance. Coordinate ethics committee submissions and meeting logistics. Follow-up with vendors, clients, and sponsor representatives. Data Entry & Report Generation: Enter study-related information into clinical systems or spreadsheets. Support tracking of study progress, adverse events, and document status. Facility & IT Support Coordination: Coordinate with IT for user accounts, system access, and hardware needs. Maintain access logs, security camera records (if part of responsibilities). HR & Staff Coordination Support Assist HR in scheduling interviews, onboarding/offboarding tasks. Maintain attendance, leave records, and update trackers. Help with ID cards, asset allocation forms, and induction documents. Finance/Admin Assistance Assist in processing invoices, bills, and petty cash records. Regulatory & Compliance Support (If in CRO) Support teams in preparing ethics committee submissions or regulatory file copies. Assist in formatting/stamping/printing of clinical study documents. Maintain vendor file updates and follow-up on payments if needed. Job Type: Full-time Pay: Up to ₹375,000.00 per year Benefits: Health insurance Provident Fund Schedule: Day shift Rotational shift Weekend availability Supplemental Pay: Yearly bonus Work Location: In person