Clinical Research Associate

As a Clinical Research Coordinator at our company based in Hyderabad, your role involves various responsibilities as listed below: - Requesting and receiving study-specific documents from QA. - Compiling study-specific Trial Master File (TMF) before the study begins. - Ensuring the Clinical Patient Units (CPUs) are prepared with the help of housekeeping staff. - Placing orders for materials and supplies required for the study. - Conducting self-checks on protocol training completion. - Delivering Informed Consent Document (ICD) presentations to volunteers in group settings. - Managing admission, discharge, meal distribution, reporting, and subject monitoring during the clinical study. - Supervising the activities of other study personnel like Clinical Research Technicians (CRTs) and Registered Nurses (RNs) throughout the study. - Compiling and reviewing study data to ensure compliance with Standard Operating Procedures (SOPs) and protocol during the study. - Ensuring timely compilation of study documents. - Submitting study documents (ICDs, CRFs, and TMFs) to Quality Control (QC) and Quality Assurance (QA) for review, and assisting in closing any observations in consultation with the Study Principal Investigator (PIC) or designee. - Assisting the PIC in archiving study documents. - Identifying deviations from SOPs or protocol and reporting them to the project in-charge. - Maintaining compliance and data integrity during study execution in alignment with SOPs and regulatory requirements. Qualifications and Skills Required: - Qualifications: B. Pharmacy / M. Pharm - Preferred Skills: - Communication - Time Management - Adaptability - Listening - Assertive Communication - Technical & Scientific Knowledge - Data Integrity - Procedural Knowledge (SOP) - Regulatory Awareness If you find this role aligns with your qualifications and interests, we look forward to receiving your application. As a Clinical Research Coordinator at our company based in Hyderabad, your role involves various responsibilities as listed below: - Requesting and receiving study-specific documents from QA. - Compiling study-specific Trial Master File (TMF) before the study begins. - Ensuring the Clinical Patient Units (CPUs) are prepared with the help of housekeeping staff. - Placing orders for materials and supplies required for the study. - Conducting self-checks on protocol training completion. - Delivering Informed Consent Document (ICD) presentations to volunteers in group settings. - Managing admission, discharge, meal distribution, reporting, and subject monitoring during the clinical study. - Supervising the activities of other study personnel like Clinical Research Technicians (CRTs) and Registered Nurses (RNs) throughout the study. - Compiling and reviewing study data to ensure compliance with Standard Operating Procedures (SOPs) and protocol during the study. - Ensuring timely compilation of study documents. - Submitting study documents (ICDs, CRFs, and TMFs) to Quality Control (QC) and Quality Assurance (QA) for review, and assisting in closing any observations in consultation with the Study Principal Investigator (PIC) or designee. - Assisting the PIC in archiving study documents. - Identifying deviations from SOPs or protocol and reporting them to the project in-charge. - Maintaining compliance and data integrity during study execution in alignment with SOPs and regulatory requirements. Qualifications and Skills Required: - Qualifications: B. Pharmacy / M. Pharm - Preferred Skills: - Communication - Time Management - Adaptability - Listening - Assertive Communication - Technical & Scientific Knowledge - Data Integrity - Procedural Knowledge (SOP) - Regulatory Awareness If you find this role aligns with your qualifications and interests, we look forward to receiving your application.