IND/IDE Clinical Research Monitor
The University of Wisconsin Clinical Research Office (CRO) is looking for a IND/IDE Clinical Research Monitor to join our fantastic team. This is a site-based monitoring position, located in beautiful Madison, Wisconsin, with very little traveling required. The Clinical Research Monitor is responsible for the oversight of clinical research compliance conducted at UW-Madison investigational sites. The Monitor will conduct site visits and remote 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 operating procedures. The UW CRO 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.
This position works under minimal supervision, working closely with study teams, site personnel, and monitoring manager for resolution of site issues found during monitoring.
SMPH is committed to being a diverse, equitable, inclusive and anti-racist workplace and is an Equal Employment Opportunity, Affirmative Action employer. Applications from Black, Indigenous and People of Color (BIPOC) individuals, LGBTQ+ and non-binary identities, women, persons with disabilities, military service members and veterans are strongly encouraged.
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 or devices required; 3 or more years preferred.
-Proficient knowledge of medical terminology.
-Ability to meet deadlines with high level of productivity.
-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 communication skills.
-Experience working diplomatically and tactfully when resolving problems positively and professionally with all levels of faculty and staff.
- Project management skills, including the ability to identify needs, develop action plans, and lead/manage projects to completion in a timely manner.
-Detail oriented, with strong analytical and problem-solving skills.
-Strong administrative skills, including self-direction and the ability to work independently, adhere to deadlines, maintain confidentiality and stay organized.
-Certification as a Certified Clinical Research Professional or a Certified Clinical Research Coordinator
Preferred:
-Previous experience monitoring or auditing clinical research studies.
LICENSE/CERTIFICATION:
Required
-Certification as a Certified Clinical Research Professional or a Certified Clinical Research Coordinator