Documentation Specialist in a clinical research organization Location: City: Hyderabad Department: Regulatory bodies / Quality Assurance / Ethics Committees Reports To: Head of Department Employment Type: Full-Time Gender: Male Job Summary: The Documentation Specialist is responsible for managing, organizing, and maintaining regulatory, clinical, and operational documents in compliance with applicable guidelines and company SOPs and license conditions. This role ensures accuracy, completeness, and timely availability of critical records to support audits, inspections, and operational continuity. Key Responsibilities: Develop, format, and maintain controlled documents (SOPs, protocols, study reports, manuals, etc.) Ensure version control and proper archiving of all documentation. Collaborate with cross-functional teams to obtain necessary approvals and implement document updates. Track and manage documentation workflows using electronic document management systems (EDMS). Prepare regulatory submissions and assist in compiling dossiers for regulatory bodies (e.g., CDSCO, DCGI, USFDA, EMA). Maintain master files for clinical studies and Ethics Committees (EC/IRB). Support internal and external audits by retrieving required documentation promptly. Conduct periodic document reviews and coordinate training record updates for SOP revisions. Maintain confidentiality and data integrity across all records and communication. Qualifications: Pharm-D or PG with Clinical Research Course. Minimum 2-3 years of experience in documentation, preferably in a healthcare, pharmaceutical, or CRO environment. Familiarity with GCP, ICH, and regulatory guidelines. Experience with EDMS (e.g., MasterControl, Veeva Vault) is an advantage. Excellent written and verbal communication skills. Strong attention to detail and organizational abilities. Great in coordination Preferred Skills: Knowledge of regulatory filing formats (e.g., eCTD); SUGAM PORTAL; SAE-Handling; conducting meetings and able to handle multiple clinets on daily basis. able to handle heterogeneric types of research proposals Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook). Ability to manage multiple priorities and meet deadlines. Experience in handling Ethics Committee or regulatory submissions is a plus. Job Types: Full-time, Fresher Pay: ₹18,883.04 - ₹21,319.24 per month Benefits: Health insurance Provident Fund Schedule: Day shift Rotational shift Weekend availability Supplemental Pay: Overtime pay Performance bonus Yearly bonus Work Location: In person Application Deadline: 30/06/2025

Job Title : Clinical Trial Assistant (CTA) Location : Hyderabad, Punjagutta Officers Colony, 702 & 801, Pavani Prestige Commercial complex, Piller no 1074, Punjagutta. Organization : Forward Life Pvt Ltd [Clinical Research Organization] Employment Type : Full-Time/ Rotational Shifts Gender : Male Job Summary: The Clinical Trial Assistant (CTA) provides administrative and operational support to clinical research teams to ensure the smooth execution of clinical trials in compliance with National and international regulatory guidelines, Good Clinical Practice (GCP), and organizational procedures, policies and standards. The CTA collaborates with clinical research coordinators, investigators, and other stakeholders to facilitate trial activities, maintain documentation, assist the project management in fulfilling the delivery of the new study feasibilities and ensure velocity of the delivery, study and data integrity. Key Responsibilities: 1. Administrative Support: - Assist in the preparation, maintenance, and tracking of clinical trial documentation, including protocols, investigator brochures, informed consent forms, and regulatory submissions. - Organize and maintain Trial Master Files (TMF) and ensure they are audit-ready. - Schedule meetings, prepare agendas, and document minutes for study team meetings. 2.Study Coordination: - Support clinical trial start-up activities, including site identification, feasibility assessments, and preparation of site initiation materials. - Coordinate the distribution and collection of essential documents from clinical trial sites. - Assist with the preparation and submission of Institutional Review Board (IRB)/Ethics Committee (EC) applications and amendments. 3. Data Management: - Enter and verify data in electronic data capture (EDC) systems, ensuring accuracy and compliance with protocols. - Assist in resolving data queries and discrepancies in collaboration with data management teams. - Track patient recruitment, screening, and enrollment to ensure trial timelines are met. 4.Regulatory Compliance: - Ensure all trial activities adhere to GCP, FDA, ICH, and other applicable regulatory requirements. - Assist in preparing for audits and inspections by regulatory authorities or sponsors. - Monitor and track regulatory documents, including investigator agreements, CVs, and financial disclosures. 5. Logistics and Communication: - co-ordinating with project managers for the client related works, regulatory services, websites data, coordination's, presentations on the data and follwing quality/compliance systems - Coordinate the shipment of study materials, investigational products, and laboratory kits to trial sites. - Serve as a point of contact for clinical trial sites, addressing queries and escalating issues as needed. - Liaise with vendors, such as central laboratories or couriers, to ensure timely delivery of services. 6. Training and Support: - Assist in training site staff on study protocols, procedures, and systems. - Support clinical research coordinators and project managers with ad-hoc tasks as required. open to learn the new technology and incorporate the management insights in day to day operations for velocity of the milestones and fulfilling the intentions of the division/Projects. Qualifications and Skills: Education : Pharm D Experience : 0-2 years of experience in clinical research or a related field (entry-level candidates encouraged to apply). - Prior experience with clinical trial documentation, TMF, or EDC systems is a plus. Skills: - Strong organizational and time-management skills with attention to detail. - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and clinical trial software (e.g., CTMS, EDC). - Basic understanding of GCP, FDA, and ICH guidelines. - Excellent written and verbal communication skills. - Ability to work independently and collaboratively in a fast-paced environment. - Certifications: GCP certification or willingness to obtain within the first 3 months of employment. Key Competencies: - Problem-solving and critical-thinking skills. - Ability to prioritize tasks and manage multiple deadlines. - Strong interpersonal skills for effective collaboration with cross-functional teams and external partners. - Adaptability to changing project requirements and timelines. Working Conditions: - May require occasional travel to clinical trial sites or sponsor meetings. - Ability to work flexible hours to accommodate global time zones, if applicable. - Primarily office-based or remote, depending on organizational policies. Compensation and Benefits: - Competitive salary based on experience and qualifications. - Health, dental, and vision insurance. - Paid time off and holidays. - Opportunities for professional development and career advancement. Job Types: Full-time, Fresher Pay: ₹19,086.00 - ₹22,842.39 per month Benefits: Health insurance Provident Fund Schedule: Day shift Rotational shift Weekend availability Supplemental Pay: Overtime pay Performance bonus Yearly bonus Work Location: In person Application Deadline: 30/06/2025 Expected Start Date: 25/06/2025

Job Title : Clinical Trial Assistant (CTA) Location : Hyderabad, Punjagutta Officers Colony, 702 & 801, Pavani Prestige Commercial complex, Piller no 1074, Punjagutta. Organization : Forward Life Pvt Ltd [Clinical Research Organization] Employment Type : Full-Time/ Rotational Shifts Gender : Male Job Summary: The Clinical Trial Assistant (CTA) provides administrative and operational support to clinical research teams to ensure the smooth execution of clinical trials in compliance with National and international regulatory guidelines, Good Clinical Practice (GCP), and organizational procedures, policies and standards. The CTA collaborates with clinical research coordinators, investigators, and other stakeholders to facilitate trial activities, maintain documentation, assist the project management in fulfilling the delivery of the new study feasibilities and ensure velocity of the delivery, study and data integrity. Key Responsibilities: 1. Administrative Support: - Assist in the preparation, maintenance, and tracking of clinical trial documentation, including protocols, investigator brochures, informed consent forms, and regulatory submissions. - Organize and maintain Trial Master Files (TMF) and ensure they are audit-ready. - Schedule meetings, prepare agendas, and document minutes for study team meetings. 2.Study Coordination: - Support clinical trial start-up activities, including site identification, feasibility assessments, and preparation of site initiation materials. - Coordinate the distribution and collection of essential documents from clinical trial sites. - Assist with the preparation and submission of Institutional Review Board (IRB)/Ethics Committee (EC) applications and amendments. 3. Data Management: - Enter and verify data in electronic data capture (EDC) systems, ensuring accuracy and compliance with protocols. - Assist in resolving data queries and discrepancies in collaboration with data management teams. - Track patient recruitment, screening, and enrollment to ensure trial timelines are met. 4.Regulatory Compliance: - Ensure all trial activities adhere to GCP, FDA, ICH, and other applicable regulatory requirements. - Assist in preparing for audits and inspections by regulatory authorities or sponsors. - Monitor and track regulatory documents, including investigator agreements, CVs, and financial disclosures. 5. Logistics and Communication: - co-ordinating with project managers for the client related works, regulatory services, websites data, coordination's, presentations on the data and follwing quality/compliance systems - Coordinate the shipment of study materials, investigational products, and laboratory kits to trial sites. - Serve as a point of contact for clinical trial sites, addressing queries and escalating issues as needed. - Liaise with vendors, such as central laboratories or couriers, to ensure timely delivery of services. 6. Training and Support: - Assist in training site staff on study protocols, procedures, and systems. - Support clinical research coordinators and project managers with ad-hoc tasks as required. open to learn the new technology and incorporate the management insights in day to day operations for velocity of the milestones and fulfilling the intentions of the division/Projects. Qualifications and Skills: Education : Pharm D Experience : 0-2 years of experience in clinical research or a related field (entry-level candidates encouraged to apply). - Prior experience with clinical trial documentation, TMF, or EDC systems is a plus. Skills: - Strong organizational and time-management skills with attention to detail. - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and clinical trial software (e.g., CTMS, EDC). - Basic understanding of GCP, FDA, and ICH guidelines. - Excellent written and verbal communication skills. - Ability to work independently and collaboratively in a fast-paced environment. - Certifications: GCP certification or willingness to obtain within the first 3 months of employment. Key Competencies: - Problem-solving and critical-thinking skills. - Ability to prioritize tasks and manage multiple deadlines. - Strong interpersonal skills for effective collaboration with cross-functional teams and external partners. - Adaptability to changing project requirements and timelines. Working Conditions: - May require occasional travel to clinical trial sites or sponsor meetings. - Ability to work flexible hours to accommodate global time zones, if applicable. - Primarily office-based or remote, depending on organizational policies. Compensation and Benefits: - Competitive salary based on experience and qualifications. - Health, dental, and vision insurance. - Paid time off and holidays. - Opportunities for professional development and career advancement. Job Types: Full-time, Fresher Pay: ₹19,086.00 - ₹22,842.39 per month Benefits: Health insurance Provident Fund Schedule: Day shift Rotational shift Weekend availability Supplemental Pay: Overtime pay Performance bonus Yearly bonus Work Location: In person Application Deadline: 30/06/2025 Expected Start Date: 25/06/2025