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
COVID-19 Considerations:
UW-Madison continues to follow necessary health and safety protocols to protect our campus from COVID-19. All employees remain subject to the COVID-19 Workplace Safety Policy: https://policy.wisc.edu/library/UW-5086. Please visit https://covidresponse.wisc.edu for the most up-to-date information.
Work Type:
Full Time: 100%
This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.
Appointment Type, Duration:
Ongoing/Renewable
Salary:
Minimum $60,000 ANNUAL (12 months) Depending on Qualifications
Additional Information:
The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. University sponsorship is not available for this position.
How to Apply:
To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications relevant to the position. You will also be asked to provide contact information for three (3) references, including your current/most recent supervisor during the application process. References will not be contacted without prior notice.
Contact:
Kim Mcfarlane [email protected] 608-263-1130 Relay Access (WTRS): 7-1-1 (out-of-state: TTY: 800.947.3529, STS: 800.833.7637) and above Phone number (See RELAY_SERVICE for further information. )
Official Title:
Clinical Research Monitor(RE111)
Department(s):
A532700-MEDICAL SCHOOL/CLINICAL RESEARCH
Employment Class:
Academic Staff-Renewable
Job Number:
257964-AS
The University of Wisconsin is an Equal Opportunity and Affirmative Action Employer. We promote excellence through diversity and encourage all qualified individuals to apply.
Employment will require a criminal background check. It will also require you and your references to answer questions regarding sexual violence and sexual harassment.
The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).
The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.
The University of Wisconsin–Madison has been a catalyst for the extraordinary since its founding in 1848. Our students, staff, and faculty partake in world-class education and conduct prolific research that solves real-world problems. Our guiding principle is the Wisconsin Idea, a commitment to outreach that creates a better future for our state, our nation, and the world. We value the contributions of each person and recognize that diversity is a source of strength, creativity, and innovation.
