Central Clinical Research Associate

1. Feasibility Activities:

o Involvement in the site selection process together with the Registries Team.

2. 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 with investigational sites and other stakeholders as applicable.

o Liaise with Vendor for different activities (startup, onsite monitoring).

5. Safety & Quality:

• Assure adequate safety reporting process of the site, and that site is submitting and/or
• undefined
• 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. Study administration:

• To maintain all the tables, trackers and databases updated to follow the study progress
• undefined
• To know and use all the tools needed.
• Participates in the investigator payment process, if applicable
• 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.
• Study Meetings: To participate with the rest of the study 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.
• 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 …

Technical skills: Good Clinical Practice (GCP): Understanding and adherence to GCP guidelines. Regulatory Requirements: Knowledge of regulatory requirements and guidelines (FDA, EMA, etc.).Clinical Trial Processes: Familiarity with clinical trial phases, protocols, and methodologies. Data Management: Skills in data collection, analysis, and reporting. Medical Terminology: Proficiency in medical terminology and procedures. Competent with Microsoft Office products.

Education: Degree in a Pharma/scientific discipline or a related Life science degree

Languages: High Proficiency in written and spoken English. Pursue progress, discover extraordinary. 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. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!