Overview:
The role of Clinical Research Specialist II involves offering clinical assistance for research endeavors led by primary investigators. With moderate oversight, this position collaborates with study staff to aid in the implementation and execution of subject follow-up appointments.
Responsibilities:
- Conducts basic medical duties like checking vital signs to aid in patient follow-up appointments and is also capable of carrying out more complex responsibilities such as administering ECGs, PFTs, drawing blood, and giving medications.
- Gathers information from a variety of outlets like patient files, health records, discussions, and tests, then creates thorough records to guarantee precise and dependable research data analysis.
- Supports in the regulatory process by presenting research plans, consent forms, and recruitment materials to the Institutional Review Board and department for review in the medical institution, ensuring adherence to regulations for hospital research endeavors.
- Coordinates research projects with minimal patient risk, including registry and biospecimen collection studies, and effectively manages the initiation, monitoring, and closure of study sites, while maintaining compliance with protocol standards and regulatory mandates.
- Support is offered in ensuring that research procedures are in line with regulations and that measures are in place to maintain the accuracy and trustworthiness of research results by complying with regulatory standards and overseeing study protocols and data handling.
- Sources and evaluates potential candidates for research participation and secures consent from individuals involved in the study.
- Assesses updated procedures for biological sample specifications, confirms the availability of essential materials at the location, and supervises the processing of biological samples for transportation to external labs, facilitating the precise and prompt assessment of study specimens.
- Carries out additional tasks as required.
Qualifications:
EDUCATION:
Required:
- High school diploma or equivalent
EXPERIENCE:
Required:
- 2 years clinical experience; 1 year clinical research experience including consenting patients.
LICENSURE/CERTIFICATION/REGISTRY/LISTING:REQUIRED
Required:
Healthcare/Health-related certification
