What are the responsibilities and job description for the Clinical Research Specialist-CCTO position at WCM-Q?
Position Summary
Under general direction, the Clinical Research Specialist is responsible for the administration, execution, and overall management of clinical research studies.
Job Responsibilities
- Coordinate clinical trials in compliance with federal regulations, GCP guidelines, and internal policies. Ensures prioritization and execution of protocol procedures. Servers as primary contact for study related issues.
- Responsible for subject management. Works closely with the research team to facilitate the screening, enrollment, and treatment of research subjects in compliance with established regulations and guidelines and internal SOPs.
- Assists with eligibility assessment and informed consent process, as appropriate. Performs central subject registration for specified research studies. Provide clinic support, as needed.
- Responsible for subject tracking in OnCore and assists with verification of research related charges.
- Function as primary liaison with sponsoring agencies and external sites.
- Coordinates site visits and audits of clinical trials in conjunction with all pertinent staff, including : the monitor / auditor, the regulatory office, investigational pharmacy, and investigators.
- Maintains and disseminates accurate listings of active and potential studies to participating investigators. Serves as the resource for information on assigned protocols and other investigational research activities. Facilitates research team meetings.
- Facilitate sample collection, processing and storage activities as required by protocols.
- Prepare deviations and Serious Adverse Events (SAEs) reports for the Institutional Review Board and other agencies.
- Assists with regulatory submissions, including the Protocol Review and Monitoring Committee (PRMC, the Institutional Review Board (IRB) and ancillary committees, as needed.
- Assist with short-term projects and provide cross-coverage to various research members, as needed.
- Attends conferences and disseminates information to clinical staff.
Education
Experience
Knowledge, Skills and Abilities
Licenses and Certifications
Working Conditions / Physical Demands
Salary : $70,000 - $82,100
