Clinical Research Assistant-Cary, NC

PM Pediatrics•Cary, NC

17h

About The Position

It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. Summary 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. Description 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.

Requirements

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

Responsibilities

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