Clinical Research Co-ordinator

As the Clinical Trials Coordinator, you will be responsible for overseeing the clinical trials start-up process, from the receipt of protocols through the Scientific Review Committee and IRB submissions, as well as site activation activities. Your duties will include data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries. Key Responsibilities: - Prepare and/or complete regulatory-related reports and IRB submissions. - Maintain and organize study regulatory binders, entering all required study data on an ongoing basis. - Ensure all study-related samples are collected, properly prepared, and shipped according to protocol requirements and IATA/DOT regulations. - Organize and prepare for both internal and external auditing and study monitoring visits. - Coordinate and manage clinical trials, including communication with sponsors and regulatory authorities. - Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved. - Interact with study participants as directed/required by the protocol and/or study team. - May be responsible for tissue sample work. Qualifications Required: - Bachelor's degree preferred. - Minimum of 1 year of total work experience preferred. Please note that this is a full-time position located in Hyderabad, Telangana. Reliable commuting or planning to relocate before starting work is required. The company provides internet reimbursement as a benefit. As the Clinical Trials Coordinator, you will be responsible for overseeing the clinical trials start-up process, from the receipt of protocols through the Scientific Review Committee and IRB submissions, as well as site activation activities. Your duties will include data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries. Key Responsibilities: - Prepare and/or complete regulatory-related reports and IRB submissions. - Maintain and organize study regulatory binders, entering all required study data on an ongoing basis. - Ensure all study-related samples are collected, properly prepared, and shipped according to protocol requirements and IATA/DOT regulations. - Organize and prepare for both internal and external auditing and study monitoring visits. - Coordinate and manage clinical trials, including communication with sponsors and regulatory authorities. - Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved. - Interact with study participants as directed/required by the protocol and/or study team. - May be responsible for tissue sample work. Qualifications Required: - Bachelor's degree preferred. - Minimum of 1 year of total work experience preferred. Please note that this is a full-time position located in Hyderabad, Telangana. Reliable commuting or planning to relocate before starting work is required. The company provides internet reimbursement as a benefit.