4 Protocol Deviations Jobs

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0.0 - 3.0 years

0 Lacs

karnataka

On-site

As a Clinical Research Coordinator at Analytical Project, St. John's Research Institute in Bangalore, your role will involve interaction with patients, Sponsor/CRO, IEC, Lab staff, and other departments in the institution. You will conduct the study according to ICH GCP Guidelines, SOPs, and study protocol guidelines. Your main responsibility will be to act as the main line of communication between patients, Investigators, and CROs in study conduct activities. **Key Responsibilities:** - Coordinate in screening, Audio-Video consenting, enrollment, periodic study visits, and close-out visits. - Ensure that rights and well-being of a research participant are protected throughout the study dura...

Posted 3 weeks ago

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0.0 - 3.0 years

0 Lacs

karnataka

On-site

As a Clinical Research Coordinator at Analytical Project, St. John's Research Institute in Bangalore, you will be responsible for interacting with patients, sponsors, IEC, lab staff, and other departments to conduct studies following ICH GCP Guidelines, SOPs, and study protocol guidelines. You will act as the main communication line between patients, Investigators, and CROs during study conduct activities. **Key Responsibilities:** - Coordinate in screening, Audio-Video consenting, enrolment, periodic study visits, and close out visits. - Ensure the protection of the rights and well-being of research participants throughout the study duration. - Coordinate with finance, legal, and regulatory...

Posted 3 weeks ago

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1.0 - 5.0 years

0 Lacs

hyderabad, telangana

On-site

As a Clinical Data Services Associate at Accenture, you will play a crucial role in the Clinical Data Management team. Your responsibilities will include collecting, integrating, and ensuring the availability of data at the appropriate quality and cost. You will be involved in activities such as reviewing discrepancies, generating queries, and resolving them. Additionally, you will create CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. Your expertise will help in identifying and addressing protocol deviations in the database, performing edit check validation, writing test scripts, and conducting database validation (UAT) against specified CRF/ECRF. You will also manage cli...

Posted 2 months ago

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10 - 15 years

6 - 9 Lacs

Hyderabad

Work from Office

Senior Medical Writer in Clinical Research @ Vimta Labs Ltd, Hyd Experience: 10-15 years in Medical writing field in Clinical Research BA/BE studies CTC : As per market standards Report to: Principal Investigator Clinical Primary Responsibilities: 1. Ensures that Good Clinical Practices (GCP) and NDCT (New Drugs and Clinical Trials Rules) are followed. 2. Writing and developing BA/BE and clinical trail protocols. 3. To perform literature search and preparation of feasibility. 4. Preparation of study specific informed consent forms (ICFs), case report forms (CRFs) and blood sample forms. 5. Preparation of clinical study reports (CSRs), DBE/summary tables, CS-BE tables and module 2.7.1 (M 2.7....

Posted 5 months ago

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