Clinical Research Specialist

• Why ThedaCare?
• Living A Life Inspired!
• Our new vision at ThedaCare is bold, ambitious, and ignited by a shared passion to provide outstanding care.
• We are inspired to reinvent health care by becoming a proactive partner in health, enriching the lives of all and creating value in everything we do.
• Each of us are called to take action in delivering higher standards of care, lower costs and a healthier future for our patients, our families, our communities and our world.
• At ThedaCare, our team members are empowered to be the catalyst of change through our values of compassion, excellence, leadership, innovation, and agility.
• A career means much more than excellent compensation and benefits.
• Our team members are supported by continued opportunities for learning and development, accessible and transparent leadership, and a commitment to work/life balance.
• If you’re interested in joining a health care system that is changing the face of care and well-being in our community, we encourage you to explore a future with ThedaCare.
• Benefits, with a whole-person approach to wellness – Lifestyle Engagement e.g. health coaches, relaxation rooms, health focused apps (Wonder, Ripple), mental health support Access & Affordability e.g. minimal or zero copays, team member cost sharing premiums, daycare About ThedaCare!
• Summary : 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.