Clinical Research Specialist

About the role

The Clinical Research Specialist works independently and inter-dependently in collaboration with the research team to provide study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Compiles and reports on each study including information related to protocol activity, accrual data, and workload. Job Description: KEY ACCOUNTABILITIES: 1. In collaboration with other research team members, creates an environment to ensure the conduct of clinical research according to the protocol, complying with study, sponsor institutional, and state and federal requirements. 2. Maintains accurate source documents related to all research procedures. 3. Participates in monitoring and auditing activities. 4. Participates in protocol activities for a number of trials including assessing patient eligibility, recruitment, conduct of trial visits according to the protocol, and ensuring quality data collection. 5. For each study, tracks adverse events, serious adverse events, protocol deviations, and unanticipated problems (UPIRSO) in accordance with local and federal guidelines. Provides input to the PI regarding reporting requirements to the sponsor, institution, and IRB. 6. Assists with organizing and scheduling assessments, tests, and activities to meet research objective and study protocol compliance. 7. Collects, records, and enters data into various databases. 8. Ensures human subject protection within the conduct of clinical trials per federal regulations and guidance documents. 9. Collects, processes, ships, and tracks biological samples according to protocol within specified timeframes to comply with federal regulations.