Clinical Research Assistant
Behavioral Health Market Context
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Qualifications
- •Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies
- •Engages participants/LARs in the informed consent process according to institutional policies
- •Strong communication skills a must
- •Must have demonstrated problem-solving skills
- •The ability to recognize and report when team members appear to exhibit unsafe behavior or performance
- •2 more items(s)
Responsibilities
- •The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member
- •The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations
- •In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies
- •Responsible for conducting research
- •Consistently demonstrates adherence to the standards for the responsible conduct of research
- •Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator
- •Stays informed of and adheres to institutional policies and federal regulations (e.g
- •Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information
- •Uses research funds and resources appropriately
- •Maintains confidentiality of data as required
- •Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility
- •Accurately creates, completes, maintains and organizes study documents
- •Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives
- •Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned
- •Attends study meetings, which could include overnight travel, as requested by principal investigator
- •Adheres to the IRB-approved recruitment plan
- •13 more items(s)
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