CLINICAL RESEARCH MONITOR

Location
Wisconsin, United States
Salary
Salary Not Specified
Posted
Jun 08, 2021
Employment Type
Full Time
Job no: 235687-AS
Work type: Staff-Full Time
Department: SMPH/CLINICAL RESEARCH
Location: Madison
Categories: Communications, Editing, Broadcasting, Media, Health Care, Medical, Social Services, Laboratory Technician, Research Specialists, Quality, Risk Management and Compliance, Research, Scientific, Project Management



Position Summary:

The Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites. Performs monitoring activities on clinical trials to ensure studies are complying and being conducted according with study protocols, current FDA regulations, applicable ICH/GCP guidelines, IRB/EC policies, state and federal law, and University of Wisconsin standard operating procedures.

This position works under minimal supervision, working closely with study teams, site personnel, and monitoring supervisor for resolution of site issues found during monitoring.

The Monitor may conduct site visits and remote monitoring in accordance with the study monitoring plan. The Monitor is also responsible for identifying and escalating protocol deviations, noncompliance, and data discrepancies to ensure compliance with the study protocols and all applicable regulatory frameworks.

The School of Medicine and Public Health has a deep and profound commitment in diversity both as an end in itself, but also as a valuable means for eliminating health disparities. As such, we strongly encourage applicants from candidates who foster and promote the values of diversity and inclusion.

Position Duties:

List of Duties

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

Degree and Area of Specialization:

Bachelor's degree required; preferred focus: health care, biology or related field.

Minimum Years and Type of Relevant Work Experience:

Required:
-At least 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

Preferred:
-Previous experience monitoring or auditing clinical research studies is preferred.

Prefix assignment determined by years of relevant work experience.

A minimum of 7 years' experience is required for appointment at the senior level.

License or Certificate:

Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), and/or Certified Clinical Research Administrator (CCRA) certification required.

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.

Department(s):

A532700-MEDICAL SCHOOL/CLINICAL RESEARCH

Work Type:

Full Time: 100%

Appointment Type, Duration:

Ongoing/Renewable

Salary:

Minimum $48,000 ANNUAL (12 months)
Depending on Qualifications

Instructions to Applicants:

Please click "" to start the application process. You will be required to submit a cover letter and resume for consideration. Your cover letter should highlight your experience and skills as they relate to the listed qualifications for maximum consideration.

This application will also require submission of three professional references, including your current or most recent supervisor. References will not be contacted without advance notice.

Contact:

Kim Mcfarlane
kmmcfarlane@wisc.edu
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:

SR ADMIN PRGM SPEC(R07BN) or ADMIN PROGRAM SPEC(R07DN) or ASSOC ADMIN PRGM SPEC(R07FN)

Employment Class:

Academic Staff-Renewable

Job Number:

235687-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.

If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: https://employeedisabilities.wisc.edu/disability-accommodation-information-for-applicants/

The University of Wisconsin-Madison is engaged in a Title and Total Compensation (TTC) Project to redesign job titles and compensation structures. As a result of the TTC project, official job titles on current job postings may change. Job duties and responsibilities will remain the same. For more information please visit: https://hr.wisc.edu/title-and-total-compensation-study/ .

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 .

Applications Open: Jun 8 2021 Central Daylight Time
Applications Close: Jun 22 2021 11:55 PM Central Daylight Time

Similar jobs

Similar jobs