About this Clinical Research Specialist role at ThedaCare
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
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.
QUALIFICATIONS:
• High school diploma or GED
• Certification in a related allied health profession from an appropriately accredited institution
PHYSICAL DEMANDS:
• Ability to move freely (standing, stooping, walking, bending, pushing, and pulling) and lift up to a maximum of twenty-five (25) pounds without assistance
• Job classification is not exposed to blood borne pathogens (blood or bodily fluids) while performing job duties
WORK ENVIRONMENT:
• Normally works in climate controlled office environment
• Frequent sitting with movement throughout office space • Consistent use of computers throughout the work day
• Frequent use of keyboard with repetitive motion of hands, wrists, and fingers
