The Clinical Research Specialist II position provides clinical support for research projects initiated and conducted by principal investigators. Under general supervision, this position works with study personnel to assist in completing and conducting subject follow-up visits.
Essential Job Function:
Performs simple clinical tasks (e.g., obtaining vital signs) to support subject follow-up visits, and may perform more advanced tasks (i.e., electrocardiogram (ECG), pulmonary function tests (PFT), phlebotomy, drug administration, etc.).
Collects data from various sources, including patient charts, medical records, interviews, and diagnostic tests, and prepares comprehensive documentation, ensuring the accurate and reliable analysis of research data.
Assists in the preparation and maintenance of study and subject-level documentation, reports, and other materials, keeping accurate records and organizing study materials efficiently, facilitating smooth research operations.
Provides support in proper research protocol compliance and development, including regulatory controls, study procedures, and data management, ensuring adherence to regulatory standards and promoting the reliability and validity of research outcomes.
Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital/medical group setting.
Serves as study coordinator for studies with low risk to patients, such as registry and biospecimen collection studies, successfully coordinating site initiation visits, monitoring visits, and close-out visits, while ensuring adherence to protocol guidelines and regulatory requirements.
Recruits and screens prospective research participants and obtain informed consent from study participants.
Reviews new protocols for biological specimen requirements, ensures all necessary supplies are on-site, and prepares or oversees the preparation of biological specimens for shipment to reference laboratories, supporting the efficient and accurate analysis of research samples.
Prepares for site initiation, monitoring, and audit visits, supporting smooth and compliant research processes and maintaining a high standard of research conduct.
Performs other duties as assigned.
Education:
Required: High School Diploma or equivalent.
Experience:
Required: 2 years clinical experience; 1-year clinical research experience including consenting patients.