Clinical Research Specialist

ThedaCare; United States; On-site; USD 60,000 - 90,000; Full time

Job summary

ThedaCare in Wisconsin is seeking a Clinical Research Specialist to coordinate studies, screen potential patients for protocol eligibility, present non-medical trial concepts, and participate in informed consent. You will ensure accurate source documents, data collection and timely reporting to sponsors, and help manage multi-trial activity while maintaining regulatory compliance and patient safety.

This role requires independence, collaboration with the research team, and a commitment to

Qualifications

• High school diploma or GED.
• Certification in a related allied health profession from an appropriately accredited institution.

Responsibilities

• Collaborates with the research team to ensure conduct of clinical research according to protocol and regulatory requirements.
• Maintains accurate source documents and data collection for multiple trials.
• Monitors and conducts protocol activities including eligibility assessment and participant recruitment.
• Tracks adverse events and protocol deviations in line with federal guidelines and sponsor reporting requirements.
• Collects, processes, ships, and tracks biological samples per protocol timelines.

Education

High school diploma or GED

Certification in a related allied health profession from an appropriately accredited institution

Job description

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.

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

Scheduled Weekly Hours: 40 Scheduled FTE: 1 Location: ThedaCare Regional Cancer Center - Appleton,Wisconsin Overtime Exempt: No Worker Shift Details: Days

About ThedaCare ThedaCare is a community health system consisting of seven hospitals, numerous clinics and related services.We are the third largest health care employer in Wisconsin and the largest employer in the state's second largest economic market - Northeast Wisconsin - with approximately 6,800 employees. Through our 100-year history, ThedaCare has woven itself into the very fabric of the communities we serve. For our employees, ThedaCare offers an environment that not only welcomes but also encourages innovative thinking and fresh approaches to today’s health care challenges. We’ve improved the health of thousands of individuals. We know this because we track our quality and constantly seek to improve our care and services for the members of our communities.

This job posting is available in other languages besides English free of charge.

ThedaCare is an Equal Opportunity Employer. ThedaCare complies with applicable Federal civil rights laws and does not discriminate on the basis of race, ancestry, color, religion, sex, gender identity, age, marital status, sexual orientation, national origin, medical condition, disability, veteran status, or any other basis protected by law.