[Hiring] SSU CRA I @Syneos Health

Role Description

The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV trials in the country in accordance with monitoring procedures and processes following ICH/GCP, local regulations and SOPs.

• Proactive site preparation and early identification of real site needs and issues.
• Close handover to execution CRA for all sites is key (from issue management to risk identification).

Job Responsibilities

• Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead, the SSO Study Start-Up Manager, and the SSO Feasibility Manager as well as the SSO Site Partnership Manager.
• Collaborates with the SSO Study Start-Up Manager, the SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments.
• Accountable for timely start-up activities from country allocation until site greenlight at assigned sites.
• Conducts site selection visits, verifies site eligibility for a specific study.
• Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation.
• Ensures that milestones (KPIs) and time schedule for study start-up are met as planned.
• Facilitates the preparation and collection of site and country level documents.
• Collects submission-related site-specific documents for all relevant site personnel within agreed timelines (e.g., FD, CV, GCP certificates, DSL, etc.).
• Supports the SSU Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
• Supports the SSO Study Start-Up Manager and assigned sites with vendor set-up activities.
• Prepares and finalizes site specific documents for submission.
• Negotiates investigator payments, as needed.
• Supports preparation of financial contracts between the client and investigational sites and investigators, as needed.
• Updates all systems until site Green Light on an ongoing basis.
• Supports preparation of audits and inspections, as applicable.
• Supports reduction of formal site-specific IRB/IEC deficiencies.
• Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness.
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
• Implements innovative and efficient processes which are aligned with the client strategy.
• Ensures sites are prepared for “Green Light” and is accountable to send the Green Light to the SSU Manager for review and approval.

Activities & Interfaces

• Externally facing role with impact on Principal Investigators and Institution/Site business offices.
• External engagements with vendor partners to lead site issue resolution as needed.
• Partners with execution Clinical Research Associate to ensure seamless transition of site responsibility at time of site initiation.

Key Performance Indicators

• Performs against study commitments at the site level (actual vs. planned patients), including set-up/delivery of trials per defined timelines and milestones (IRB/IEC & HA approval, RIS, SIV) and data quality requirements.
• Delivers study milestones in accordance with prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
• Actively shares insights with relevant internal stakeholders to drive site and account development.
• Partners with execution Clinical Research Associate to ensure seamless transition of site responsibility.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.