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Form of workAre you looking to contribute to groundbreaking research? We look forward to having you join our team to collaborate on groundbreaking research!
The Clinical Research Specialist provides Clinical Research expertise by participating in the design and implementation of research projects and care of research patients as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
- Coordinates research projects at an institutional or departmental level. Serves as an internal consultant for specific departmental activities.
- Communicates project status and improvement areas with leadership in a timely manner. Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
- Provides mentorship regarding project planning, project logistics, and project implementation
- Participates in required training and education programs. Participates in weekly research staff meetings.
- Provides clinical expertise and support with quality assurance, performance improvement, and health plan compliance for clinical trial compliance.
- Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according FDA, HSPC, HIPAA an d other agency guidelines
- Completes appropriate IRB paperwork and submission/filing of internal and external SAEs to IRB. Responsible for insuring timely submission of complete, accurate and neat documents to research sponsors, IRB, and contract research organizations, where applicable.
- Acts as a liaison with Principal Investigators, pharmaceutical company representatives and other project funding organizations to supervise and update project progress.
- Prepares for institutional, pharmaceutical and internal audits, including facilitating third party study monitoring.
- Attends site feasibility visits and site initiation visits for potential studies, and assures that new studies are implemented according to protocol
- Review pertinent medical records to determine opportunities for quality improvement. Analyze quality metric data in support of the Principal Investigator and Director of Clinical Services. Recommend and implement process improvement efforts.
- Assists with procedures, and supports related patient care when required during data collection process.
Educational Requirements:
Bachelor's Degree in related field preferred.
Master's Degree Preferred.
Licenses:
Basic Life Support (BLS) Certification needs to be the AHA Healthcare Provider Type Only, required/
SoCRA or ACRP or comparable certification
Experience:
5 years of experience in Clinical Research required.
5 years experience in IRB Clinical Research application procedures. Related experience in Pharmaceutical/Biotechnology, or Contract Research Organization (CRO), preferred.
5years experience in Phase I, II, III, IV clinical trials and investigator initiated trials, preferred
Physical Demands:
Lifting, standing, walking, sitting
