Clinical Research Specialist II
Clinical Research Specialist II
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Overview
Responsibilities
- Performs simple clinical tasks (e.g. obtaining vital signs) to support subject followup 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 subjectlevel 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 closeout visits while ensuring adherence to protocol guidelines and regulatory requirements.
- Recruits and screens prospective research participants and obtains informed consent from study participants.
- Reviews new protocols for biological specimen requirements ensures all necessary supplies are onsite 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.
Qualifications
Required Experience:
Unclear Seniority
Employment Type
Full-Time
