Clinical Research Coordinator Senior underfill Clinical Research Coordinator Intermediate
- Excellent medical, dental and vision coverage effective on your very first day
- 2:1 Match on retirement savings
- Scientific Concepts and Research Design
- Ethical Participant Safety Considerations
- Investigational Products Development and Regulation
- Clinical Study Operations (GCPs)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication and Teamwork
- Develops tools, processes, and training to enhance the administration and execution of clinical trials.
- Designs processes and tools to assess study execution and leads team on accurate implementation of protocol.
- Develops processes, tools, and training to support the non-GCP-related activities associated with study execution.
- Performs study procedures at the highest levels and mentors team members in accurate completion of study procedures.
- Develops processes and tools, and mentors study team in best practices for addressing subject concerns efficiently.
- Oversees data quality.
- Performs at the highest level of data management and results reporting.
- Develop processes, tools, and training to enhance site compliance with the requirements necessary for the safe and effective development of investigational products.
- Monitors site compliance with subject safety reporting, escalate issues, and develops tools, processes, and training to enhance subject safety during the conduct of a clinical study
- Leads a team of coordinators in support of clinical research.
- Functional supervision of clinical research staff and temporary staff.
- Demonstrates professionalism and applies well-developed leadership practices in all aspects of the role of the CRC.
- Oversees study conducted by staff and guides quality assurance efforts.
- Responsible for recommendations on workload assessments and distribution.
- Develops processes, tools, and training to support the GCP-related activities associated with study execution.
- All training requirements of previous level.
- Develops and conducts training for staff and others.
- Other duties as assigned.
- CRC Governance Committee review and approval
- Bachelors degree in Health Science or an equivalent combination of related education and experience is necessary.
- Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire.
- Minimum 5 years of directly related experience in clinical research and clinical trials is necessary.
- Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
- Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
- Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoC
- Masters Degree in Health Science or an equivalent combination of related education and related experience is desirable.
- 9+ years of direct related experience
- Experience in data entry and monitoring, including the use of Excel and Redcap
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