Central Clinical Research Associate

Job title : Central CRA (Clinical Research Associate)- Registries • Hiring Manager: Team Lead – Registry Clinical Operations   • Location: Hyderabad • % of travel expected: Travel required as per business need • Job type: Permanent and Full time   About the job                                                           Our Team:   Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions​. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations​ in Sanofi, globally.   The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool.   Main responsibilities: The Central CRA serves as the primary liaison for the Principal Investigator and other site staff involved in conducting rare disease registries at the investigational site. 1.    Feasibility Activities: o   Involvement in the site selection process together with the Registries Team.   2.    Study Start-up Activities: • Assist in collecting site documents for submission to the Health Authority (HA)/Regulatory Authority (RA) and Ethics Committees (EC)/Institutional Review Board (IRB). •          Review and ensure the quality of site and study documents prior to submission to central, local, hospital committees, and HA/RA. •          Prepare EC cover letters and any additional required materials, if applicable. •          Follow up with EC regarding additional queries and communicate updates to sites, if applicable. •          Prepare the Insurance Certificate application, when applicable. •          Support the Site Contract process, including the collection of required site documents, budget negotiations, and final agreement with sites. •          Ensure customization of the Informed Consent Form (ICF) based on country-specific requirements, incorporating site details, and conducting quality reviews and version tracking per site, if applicable. •          Assist with uploading and filing Study Start-up documentation into the electronic Trial Master File (eTMF). •          Ensure all stakeholders are kept informed about project progress, changes, and any arising issues.   Site Monitoring: • Off-Site Visits • Perform remote site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs. • Plan, prepare, conduct, report and follow up site (and satellite sites) remote visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs. • Onsite (where local hub affiliates are located) • Perform onsite site management and other related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs. o    Plan, prepare, conduct, report and follow up Onsite site (and satellite sites) visits - Site Selection, Site Initiation, Routine Monitoring and Close Out Visits according to Study manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs. o    Perform remote site management and related activities for assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs. o    Management of the Site Data: o   Reviews study data from various sources remotely. o   Follow up of trial progress and quality control of data