IND/IDE Clinical Research Monitor

Job Summary:

UW Clinical Trials Institute (CTI) is a partnership between the University of Wisconsin School of Medicine and Public Health (SMPH) and UW Health. It supports clinical research professionals, investigators, and participants to advance discovery and research in the prevention, detection, and treatment of disease to help improve the health of individuals, families, and communities across Wisconsin and beyond. Our exceptionally talented and diverse workforce provides care, support, and provide information to clinical trials participants; resources, training, and guidance to research professionals; and opportunities for industry partners to advance groundbreaking medical research.

UW-CTI is looking for an IND/IDE Clinical research Monitor to join our fantastic team. This is primarily a site-based monitoring position located in beautiful Madison, Wisconsin. Travel may be required for multi-site studies. The Clinical Research Monitor is responsible for the oversight of clinical research compliance conducted at UW-Madison investigational sites. The Monitor will conduct a combination of site visits and remove monitoring in accordance with the study monitoring plan. The Monitor is responsible for identifying and escalating protocol deviations, noncompliance, and data discrepancies to ensure compliance with the study protocols and all applicable regulatory frameworks including but not limited to current FDA regulations, applicable ICH.GCP guidelines, IRB/EC policies, state and federal law, and University of Wisconsin standard operation procedures. This position works under minimal supervision, working closely with study teams, site personnel, and monitoring manager for resolution of site issues found during monitoring.

CTI is team-oriented where workplace environment is as important as the work we perform. We pride ourselves on being collaborative and supportive as we work together to advance medical research and help improve the health of individuals, families and communities across Wisconsin and beyond.

Responsibilities:

Performs monitoring activities on clinical trials to ensure studies are being conducted according to current FDA regulations, applicable ICH/GCP guidelines, local policies, state and federal law, and standard operating procedures.

• 40% Coordinates and conducts independent monitoring reviews in accordance with the study monitoring plan and verifies that trial data is consistent with source documentation, including review of essential documents, subject records, and investigational product records, when applicable
• 20% Adheres to and executes study-specific data monitoring plans. May assist in developing clinical trial data monitoring plans
• 20% Documents monitoring activities and communicates findings to study teams
• 5% Provides recommendations and guidance to study teams and assists in audit readiness and preparation
• 5% Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance.
• 5% Understands the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations, etc.). Possess a working knowledge of disease state and investigational product.
• 5% Attend internal department and team meeting, as requested.

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Education:

Preferred
Bachelor's Degree; preferred focus-health care, biology, or related field.

Qualifications:

Required:
- Minimum 2 years of clinical research experience involving drugs and devices required; 3 or more years preferred.
- Proficient knowledge of medical terminology
- Demonstrated knowledge of and ability to apply the rules (laws, regulations, guidance, and policies) related to the protection of human subjects, including the Common Rule, Food and Drug Administration regulations, the Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practice, and university human subjects research policy.
- Demonstrated experience using strong interpersonal, verbal and written communic