Clinical Research Specialist-CCTO
About The Position
Under general direction, the Clinical Research Specialist is responsible for the administration, execution, and overall management of clinical research studies. The role coordinates clinical trials in compliance with federal regulations, Good Clinical Practice guidelines, and internal policies, and serves as a primary contact for study-related issues. The specialist manages research subjects and works with the research team to support screening, enrollment, and treatment. The role also supports eligibility assessment, informed consent, central subject registration, clinic operations, subject tracking in OnCore, and verification of research-related charges. It serves as the primary liaison with sponsoring agencies and external sites and coordinates clinical-trial site visits and audits with relevant staff. Additional duties include maintaining and sharing study listings, serving as a resource on assigned protocols and research activities, facilitating research-team meetings, coordinating protocol-required sample collection and handling, preparing deviation and Serious Adverse Event reports, assisting with regulatory submissions, providing cross-coverage and short-term project support, and attending conferences to share information with clinical staff.
Requirements
- Bachelor's degree in science, healthcare, or a related field.
- Approximately 2 or more years of prior clinical research experience in a healthcare setting; a master's degree in a related field may substitute for experience.
- Experience conducting and carrying out protocols and coordinating research.
- Research experience in an academic health center, with exposure to a team research environment involving senior investigators, nurses, research coordinators, and lab technicians.
- Knowledge of FDA and OHRP regulations and ICH Good Clinical Practice guidelines.
- Excellent verbal and written communication skills; strong interpersonal skills and the ability to interact with multiple constituencies.
- Proficiency with Microsoft Office Suite and database applications.
- Strong organizational skills and attention to detail.
- Critical-thinking and analytical skills.
- Ability to multitask and prioritize in a fast-paced environment, remain focused despite frequent interruptions, and handle confidential information with utmost discretion.
- Professional standards in appearance, presentation, and demeanor.
- Ability to collaborate effectively with departmental faculty and staff and other institutional representatives, and to work independently as well as on a team.
Nice To Haves
- SoCRA or ACRP certification.
Responsibilities
- Coordinate clinical trials in compliance with federal regulations, GCP guidelines, and internal policies; prioritize and execute protocol procedures and serve as the primary contact for study-related issues.
- Manage research subjects and work with the research team to facilitate screening, enrollment, and treatment in compliance with applicable regulations, guidelines, and internal SOPs.
- Assist with eligibility assessment and informed consent, as appropriate; perform central subject registration for specified studies and provide clinic support as needed.
- Track subjects in OnCore and assist with verification of research-related charges.
- Serve as the primary liaison with sponsoring agencies and external sites.
- Coordinate clinical-trial site visits and audits with relevant staff, including monitors or auditors, the regulatory office, investigational pharmacy, and investigators.
- Maintain and disseminate accurate listings of active and potential studies to participating investigators; serve as a resource on assigned protocols and other investigational research activities; facilitate research-team meetings.
- Facilitate protocol-required sample collection, processing, and storage.
- Prepare deviation and Serious Adverse Event reports for the Institutional Review Board and other agencies.
- Assist with regulatory submissions, including submissions to the Protocol Review and Monitoring Committee, Institutional Review Board, and ancillary committees, as needed.
- Assist with short-term projects and provide cross-coverage to research team members as needed.
- Attend conferences and disseminate information to clinical staff.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
