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The Clinical Research Associate (CRA) is responsible and accountable for site monitoring and

site management. The CRA has responsibility for rare disease registries according to Company and

Sponsor Standard Operating Procedures (SOP), and local regulatory guidelines. The CRA is the

primary Rare Disease Registries representative for the sites.

We are seeking a CRA (CRA II to Sr. CRA level) to be r esponsible for all aspects of study site monitoring and management.

Essential duties:

The CRA is the first point of contact for the Principal Investigator and other site staff performing the rare disease registries at the Investigational Site

Feasibility Activities

• Involvement in the site selection process together with the Clinical Project Lead (CPL), Registries Regional Leadsand Local Medical Affairs.

Study Start-up Activities:

• Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
• Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.

• Prepare EC cover letter and any additional materials required
• Ensure appropriate follow-up with EC for additional questions and to inform sites
• 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
• Assist with the upload & file of Study Start-up documentation into the eTMF.

Site Monitoring:

Onsite and Off-Site Visits

Plan, prepare, conduct, report and follow up site (and satellite sites) visits - Site Selection, Site

Initiation, Routine Monitoring (Remote / On-site) and Close Out Visits according to Study

Manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs. High level of remote visits vs onsite visits considering the type of site/number of patients.

Management of the Site Data

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.

Site Management

Recruitment

Follow up on patient enrolment and patient status.

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.

Safety & Quality:

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.

To monitor the safety of registries at the site level 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.

Study administration:

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. 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.

Soft Skills

Focus on Customer

- Ability to maintain confidentiality of data and information during interactions with staff at all

levels and across studies and sponsors.

- Effective Site relationship management, site coordinator training, site staff motivation, patient pathways.

Pursue Scientific and Process Excellence

- Demonstrate ability to conduct registries operations activities effectively and efficiently.

- Good attention to detail.

- Methodical approach to work.

- Good understanding of medical and research terminology and registries processes.

- An understanding of the basics of physiology, pharmacology, and registries (when applicable).

- Good understanding of the principles of ICH-GCP and applicable local regulatory requirements.

Work with Others

- Good oral and written internal and external communication, team, and organizational skills,

personal presentation.

-Demonstrated ability and sensitivity in working across countries that may have different business cultures.

- The ability to communicate effectively in English.

Achieve Results

- Be technology oriented and comfortable with emerging technologies, mobility applications,

novel monitoring platforms and analytics tools.

- Demonstrate ability to achieve targets and deadlines through the duration of the study via

registries team objectives.

We look forward to your application and to getting to know you!

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