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Hyderabad, Telangana, India
Hybrid
Job title: Central CRA (Clinical Research Associate)- Registries
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:
• 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:
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 (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 with investigational sites and other stakeholders as applicable.
o Liaise with Vendor for different activities (startup, onsite monitoring).
5. Safety & Quality:
6. Study administration:
People: (1) Seek alignment with internal stakeholders, External stakeholders, or Principal Investigator to ensure integration and appropriate prioritization of Registry study activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business
Performance: (1) Maintain study Start-Up Timelines and Monitoring Visit Frequency and Quality which includes adherence to the monitoring plan, thoroughness of data verification, and timely resolution of issues (2) Data Quality and Integrity: accuracy and completeness of data collected at the sites. This can be assessed through the number of data queries raised and resolved, and the frequency of data discrepancies (3) Regulatory Compliance: maintaining compliance with regulatory requirements. Adherence to Good Clinical Practice (GCP) guidelines, and proper documentation. (4) Patient Recruitment and Retention: effectiveness in supporting patient recruitment and retention efforts. (5) Communication and Collaboration: ability to communicate effectively with site staff, sponsors, vendors, and regulatory bodies. This includes responsiveness, clarity of communication, and the ability to resolve conflicts. (6) Training and Development: commitment to ongoing professional development and training. This can be measured by participation in training programs and staying updated with industry best practices. (7) Efficiency in Reporting: maintaining the timeliness and accuracy of the CRA’s reports, including monitoring visit reports, progress reports,
Process:(1) Involvement in the site selection process together with the Clinical Project Lead (CPL), Registries Regional Leads and Local Medical Affairs. (2) Assist in the collection of site documents, Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee. Prepare EC cover letter and any additional materials if required. Ensure appropriate follow-up with EC for additional questions and to inform sites (if applicable). Prepare the Insurance Certificate application when applicable. Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites. 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 Assist with the upload & file of Study Start-up documentation into the eTMF. (3) Plan, prepare, conduct, report and follow up site (and satellite sites) visits-Site Selection, Site. Initiation, Routine Monitoring (Remote /) and Close Out Visits according to Study. Manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs. (4) 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. (5) Assure adequate safety reporting process of the site, and that site is submitting and/or notifying safety information to EC/IRB/RA according to country regulations, site SOP. Quality control of study conduction at site level - with "Audit/inspection readiness" mindset. Critical analysis of issues and deviations (root cause analysis) and implementing Corrective and Preventive Actions (CAPA) whenever necessary. (6) To maintain all the tables, trackers and databases updated to follow the study progress locally and globally. To know and use all the tools needed. To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required. To participate with the rest of the registries team in local and international investigators and/or monitors meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.
Stakeholder: (1) CRAs identify all relevant stakeholders, including sponsors, investigators, regulatory bodies, and patients. Understanding each stakeholder’s role and influence is essential. (2) Communication: Effective communication is vital. CRAs ensure that stakeholders are kept informed about the study’s progress, any issues that arise, and the outcomes. This involves regular updates, meetings, and reports. (3) Building Relationships: Establishing and maintaining positive relationships with stakeholders is crucial. This involves understanding their needs, expectations, and concerns, and addressing them promptly. (4) Conflict Resolution: CRAs often mediate conflicts between stakeholders. They must be adept at negotiating and finding solutions that satisfy all parties involved. (5) Compliance and Ethics: Ensuring that all stakeholders adhere to regulatory and ethical guidelines is a key responsibility. CRAs monitor compliance and address any deviations promptly. (6) Feedback and Improvement: Gathering feedback from stakeholders and using it to improve processes and outcomes is an ongoing task. This helps in building trust and improving future collaborations.
About you
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
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