Triage incoming emails, either as HelpDesk or other centralized/group email box.
Process/track/distribute/upload designated clinical trial documents/artifacts, e.g., protocol deviations, site monitoring visit reports, essential regulatory documents (ERDs), etc. Generate/distribute Monthly/Quarterly reports regarding the documentation to internal and/or external stakeholders.
Review information in centralized databases, e.g., patient recruitment/accrual, clinical data entered as EDC. Resolve queries, provide analysis assessments, and create/distribute periodic reports to internal and external stakeholders. Participate in centralized monitoring visits (CMVs).
Provide Meeting/Webinar Support, i.e., distribute invites, track attendance, and complete/distribute meeting minutes/summaries to internal and external parties.
Adherence to strict project timelines and expectations.
Troubleshoot issues by applying existing knowledge to solve new problems.
Job Requirements Requirements:
B.A/B.S. in health-related field preferred, or understanding of data and/or documentation handling
Knowledge of applicable ICH/GCP/FDA guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO setting (i.e., In-house CRA, Study Coordinator, IRB Coordinator, and Regulatory Coordinator/Associate/Specialist).
Must have excellent time management skills.
Able to identify activities along critical paths toward a specified deliverable.
Able to negotiate with stakeholders, e.g., investigators, research nurses, and site staff to reach desired goal.
Demonstrated understanding of medical and clinical trials terminology.
Able to work independently or with minimal supervision and handle multiple tasks effectively while keeping up with rapid changes of priorities without loss of efficiency.
Demonstrated understanding of sponsor-specific requirements, and Standard Operating Procedures/Project Work Instructions.
Excellent professional writing and verbal communication skills.
Must be self-motivated and have a positive attitude.
Excellent organizational and coordination skills with strong attention to detail.
According to the US Bureau of Labor Statistics (BLS), employment in life, physical, and social science occupations is projected to grow 5 percent from 2019 to 2029, faster than the average for all occupations, and will result in about 68,200 new jobs. Increasing demand for expertise in the sciences, particularly in occupations involved in biomedical research, psychology, energy management, and environmental protection, is projected to result in employment growth.
According to BLS, the median annual wage for life, physical, and social science occupations was $69,760 in May 2020, which was higher than the median wage for all occupations of $41,950.
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