CRA II/Senior (CNS), Poland
- Contract Type
Senior CRA or CRA II
Poland (preferred central area)
Home-based or Office-based
Here at Syneos Health we are currently recruiting for a CRA II or Senior CRA to be based in Poland and join our Central Nervous System Business Unit.
Main responsibilities include but are not limited to:
Critically evaluates adequacy of investigator sites (qualifications, facilities, equipment and performance). Performs all tasks required for onsite/remote monitoring including but not limited to source document review (SDR) and source document verification (SDV).
Completes and submits monitoring visit reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work.
Ensures all assigned sites are fully trained.
Extensive travel may be required, 50% to 75% on a regular basis.
2. Reporting and Tracking
Maintains site performance metrics and implements action plans for sites not meeting expectations with minimal guidance.
Maintains up to date information within the deployed CTMS.
3. Data Management
Uses analytical thinking to review data recorded in source documents for accuracy and completeness, and in accordance with the clinical monitoring and associated plans. Verifies that the clinical data entered in the case report form (CRF) is accurate and complete.
4. Investigational Product
Performs IP inventory, reconciliation and reviews storage and security. Verifies that the IP has been dispensed and administered to subjects according to the protocol. Verifies process and identifies any issues or risks associated with blinded or randomized information related to IP.
5. Documentation and Record keeping
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with that of the trial master file (TMF
Maintains effective, accurate, and timely communication with site staff and project team, ensures appropriate issue escalation.
7. Attends clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements
8. May provide training or mentorship to more junior-level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
The ideal candidate will need the following experience / skills to be considered:
- MD Degree is preferred, life sciences degree is mandatory
- Min. 3 years’ experience as a CRA with a thorough understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines.
- Comfortable in navigation within, and able to assist junior staff in: CTMS systems, Data Platforms for assigned projects, Microsoft Suite: Excel, Word, Power Point, Outlook, Site EMR systems.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
We have a comprehensive benefits package and offer highly competitive remuneration.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV.
To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/
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