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The Clinical Reviewer provides a supporting role to the project lead in the development, coordination and implementation of the management of the clinical endpoint adjudication process for clinical trials conducted by CEVA. The CEVA Clinical Reviewer will provide assistance for less experienced CEVA Clinical Reviewers.
- Assist project lead during trial start up on event reporting and endpoint eCRF / CRF critical variables / data critical to the adjudication process as needed. • Assist the project lead in the identification of source documents needed by the Endpoints Adjudication Committee (EAC) for the trial endpoints as indicated by the needs of the project with minimal guidance of Senior Clinical Reviewer. • Assist the project lead on the clinical aspects of project processes in the development of documents, forms, and workflows as indicated by the project. • Assist project lead in clinical processing training for team members. • Support project lead in collection of project metrics related to clinical processing. • Review for relevance of source documents received after submission to the EAC (re-review documents) with minimal guidance from Senior Clinical Reviewer.
- Identify potential missed events when there is evidence that an additional event occurred in combination with reported event(s).
- Query site(s) for any suspected event(s) identified during the review of source documents received from the site(s).
- Provide clinical judgment during the review of documents to determine if the existing information is sufficient for the reported clinical endpoint to be adjudicated.
- Identify and record process or quality problems, then bring them to the attention of the project lead and Senior Clinical Reviewer.
- Participate in continuous improvement of all departmental processes and procedures by identifying and implementing efficiencies in workflow and/or case processing.
- Use the Electronic Endpoint Adjudication System or other related systems for tracking, running reports, or viewing EAC related data.
- Participate in team meetings and provides feedback on challenges / issues and successes.
- Ensure compliance to Quintiles high quality standards and works with the Project Lead to achieve project and customer deliverables.
- Contribute to achievement of department goals e.g. utilization realization and productivity metrics.
- Work with the CEVA Senior Clinical Reviewer and Project Leads to identify key operational issues related to clinical endpoints and to assist in the development of appropriate processes.
- Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed within timelines and documented. Ensure individual training plan training transcript reconcile.
- Basic knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, standard operating procedures (SOPs) or the ability and willingness to gain this knowledge.
- Proficient in Microsoft Office and web-based applications.
- Good knowledge of medical terminology.
- Strong organizational skills and time management skills.
- Strong communication skills (verbal, written and aural).
- Self-motivated and flexible.
- Attentiveness to detail and accuracy; ability to maintain quality standards.
- Ability to follow instructions/guidelines, utilize initiative and work independently.
- Proven ability to multi-task, manage competing priorities and deadlines.
- Ability to delegate and mentor effectively to less experienced team members.
- Willingness and aptitude to learn new skills across all CEVA service lines.
A licensed medical or nursing professional with 3 years of clinical experience; or equivalent combination of education, training and experience.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- Occasional lifting and moving of objects.
EEO Minorities/Females/Protected Veterans/Disabled
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