Job Description
Responsibilities
- Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
- Responsible for 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.
- Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
- Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.
- Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
- Coordination and management of 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.
- Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
- Responsible for 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.
- Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
- Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.
- Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
- Coordination and management of 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.
💡 Quick Summary
Seeking a career-building opportunity? The Clinical Research Co-ordinator position is now open for candidates interested in the Lab Technician / Pharmacist Jobs sector. This role in Ahmedabad offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Lab Technician / Pharmacist Jobs is a plus.
