Central Clinical Research Associate (CRA)

Job Title: Central Clinical Research Associate (CRA)

Job Location: Hyderabad, India

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: 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.

1. Study Start-up Activities:

o Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)

o Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.

o Prepare EC cover letter and any additional materials required (if applicable)

o Ensure appropriate follow-up with EC for additional questions and to inform sites. (if applicable)

o Prepare the Insurance Certificate application when applicable.

o Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites.

o Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site. (if applicable)

o Assist with the upload & file of Study Start-up documentation into the eTMF.

o Ensure that all parties are informed about project Progress, changes, and any issues that arise.

• 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.

3Management of the Site Data:

o Reviews study data from various sources remotely.

o Follow up of trial progress and quality control of data (source document check). Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites. Escalate issue(s), when necessary. To maintain contact with Data Management group. To coordinate international data collection projects.

4. Site Management: o Recruitment Follow up on patient enrolment and patient status.

o Site facility & staff: Assure that site facilities are adequate, according to protocol needs, local regulations, GCP and applicable SOPs (global/local). Assure site staff training and access to different systems.

**o Develops collaborative relationships w...