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Clinical Research Qa & Compliance Manager

  • ... Madison, Wiltz, United States
  • ... Full time
  • ... Salary: 75000 per year
  • Posted on: Feb 02, 2024       Expires on: Mar 18, 2024

Clinical Research Qa & Compliance Manager   

JOB TITLE:

Clinical Research Qa & Compliance Manager

JOB TYPE:

Full-time

JOB LOCATION:

Madison Wiltz United States

JOB DESCRIPTION:

jpg\" height=\" 86\" width=\" 250\" alt=\"Logo\" border=\"0\"/>

Job Summary:

The Quality Assurance & Compliance Manager will function on the management team within the Clinical Research Central Office (CRCO) serving at the direction of the Assistant Director of Clinical Research for the University of Wisconsin Carbone Cancer Center (UWCCC).
The incumbent will provide quality assurance oversight and administrative support to UWCCC and Cancer Center Affiliate Network researchers and staff.
The incumbent must be able to handle multiple projects simultaneously and work independently using initiative and good judgment.
Excellent oral and written communication, coupled with strong interpersonal skills and professionalism, are necessary for success.

Responsibilities:

Manages quality assurance and compliance initiatives for a clinical research unit.
Provides quality assurance oversight and administrative support to unit research teams.
May manage clinical research compliance staff.
  • 15% Oversees all unit research activities to ensure compliance with institutional, federal, and state laws, regulations, policies, and grant requirements.
    Serves as lead for compliance questions for the unit
  • 15% Develops a strategic plan for integration of clinical research compliance into the program and clinical research protocols; and develops program goals and objectives
  • 10% Serves as administrative leader for process questions, metrics review, and overall conduct of unit compliance committees
  • 10% Contributes to education and training initiatives
  • 15% Contributes to creation of policies, standard operating procedures, work instructions, and supplemental tools that support clinical research
  • 10% Engages in risk management with internal and external stakeholders
  • 5% Contributes to grant applications and annual reports
  • 5% Serves on unit leadership team and participates in unit and/or institutional committees
  • 15% May exercise supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.
    0 FTE or equivalent employees
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: wisc.
edu\">Diversity and Inclusion

Education:

Preferred
Bachelor's Degree

Qualifications:

Minimum 4 years of experience in oncology clinical research
Supervisory/management experience of full-time staff required
Project management experience preferred

License/Certification:

Preferred
SOCRA - Certification In Clinical Research

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 $75,000 ANNUAL (12 months)
Depending on Qualifications

Additional Information:

* Work experience should demonstrate dependability, flexibility, and maturity.
Candidates must be effective at building interpersonal relationships with constructive interactions, be clear and effective communicators, promote and create collegial environments that value accountability.
Employees will also be expected to uphold UWCCC core values as defined below:
* Diversity & Inclusiveness: Embrace differences and promote fairness and equity while fostering a sense of belonging.

* Respect: Demonstrate respect for self and others -- behave professionally.

* Integrity: Act with integrity and honesty.

* Teamwork: Commit to and demonstrate teamwork.

* Excellence: Ensure excellence, quality, and high ethical standards in conduct and performance.

* TB testing and a Caregiver Background Check will be required at the time of employment.
This position has been identified as a position of trust with access to vulnerable populations.
The selected candidate will be required to pass an initial Caregiver Check to be eligible for employment under the Wisconsin Caregiver Law and then every four years.


Please note that successful applicants are responsible for ensuring their eligibility to work in the United States (i.
e.
a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without need of employer sponsorship) on or before the effective date of appointment.
How to Apply:

To apply for this position, please click on the \"Apply Now\" button.
You will be asked to upload a resume and cover letter as a part of the application process.
Please ensure that the resume and cover letter address how you meet the minimum/preferred qualifications for the position.
You will also be asked to provide three professional/supervisor references during the application process.
References will not be contacted prior to notifying you.

Contact:

Jennifer Wilkie
edu\">jwilkie@wisc.
edu

608-262-8025
Relay Access (WTRS): 7-1-1.
See wisconsinrelay.
com/\">RELAY_SERVICE
for further information.

Official Title:

Clin Res Compl Mgr(RE106)

Department(s):

A53-MEDICAL SCHOOL/CARBONE CANC CTR/CANC CTR

Employment Class:

Academic Staff-Renewable

Job Number:

293486-AS

The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.


Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies.
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: wisc.
edu/disability-accommodation-information-for-applicants/\">https://employeedisabilities.
wisc.
edu/disability-accommodation-information-for-applicants/


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 wisc.
edu/asr\">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 uwpd.
wisc.
edu\">University of Wisconsin Police Department
.

Position Details

POSTED:

Feb 02, 2024

EMPLOYMENT:

Full-time

SALARY:

75000 per year

SNAPRECRUIT ID:

S-1707247332-6a2b650dd891630faa91c5a4413472b9

LOCATION:

Wiltz United States

CITY:

Madison

Job Origin:

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Job Summary:

The Quality Assurance & Compliance Manager will function on the management team within the Clinical Research Central Office (CRCO) serving at the direction of the Assistant Director of Clinical Research for the University of Wisconsin Carbone Cancer Center (UWCCC). The incumbent will provide quality assurance oversight and administrative support to UWCCC and Cancer Center Affiliate Network researchers and staff. The incumbent must be able to handle multiple projects simultaneously and work independently using initiative and good judgment. Excellent oral and written communication, coupled with strong interpersonal skills and professionalism, are necessary for success.

Responsibilities:

Manages quality assurance and compliance initiatives for a clinical research unit. Provides quality assurance oversight and administrative support to unit research teams. May manage clinical research compliance staff.
  • 15% Oversees all unit research activities to ensure compliance with institutional, federal, and state laws, regulations, policies, and grant requirements. Serves as lead for compliance questions for the unit
  • 15% Develops a strategic plan for integration of clinical research compliance into the program and clinical research protocols; and develops program goals and objectives
  • 10% Serves as administrative leader for process questions, metrics review, and overall conduct of unit compliance committees
  • 10% Contributes to education and training initiatives
  • 15% Contributes to creation of policies, standard operating procedures, work instructions, and supplemental tools that support clinical research
  • 10% Engages in risk management with internal and external stakeholders
  • 5% Contributes to grant applications and annual reports
  • 5% Serves on unit leadership team and participates in unit and/or institutional committees
  • 15% May exercise supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 FTE or equivalent employees
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

Qualifications:

Minimum 4 years of experience in oncology clinical research
Supervisory/management experience of full-time staff required
Project management experience preferred

License/Certification:

Preferred
SOCRA - Certification In Clinical Research

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 $75,000 ANNUAL (12 months)
Depending on Qualifications

Additional Information:

* Work experience should demonstrate dependability, flexibility, and maturity. Candidates must be effective at building interpersonal relationships with constructive interactions, be clear and effective communicators, promote and create collegial environments that value accountability. Employees will also be expected to uphold UWCCC core values as defined below:
* Diversity & Inclusiveness: Embrace differences and promote fairness and equity while fostering a sense of belonging.
* Respect: Demonstrate respect for self and others -- behave professionally.
* Integrity: Act with integrity and honesty.
* Teamwork: Commit to and demonstrate teamwork.
* Excellence: Ensure excellence, quality, and high ethical standards in conduct and performance.
* TB testing and a Caregiver Background Check will be required at the time of employment. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial Caregiver Check to be eligible for employment under the Wisconsin Caregiver Law and then every four years.

Please note that successful applicants are responsible for ensuring their eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without need of employer sponsorship) on or before the effective date of appointment.How to Apply:

To apply for this position, please click on the \"Apply Now\" button. You will be asked to upload a resume and cover letter as a part of the application process. Please ensure that the resume and cover letter address how you meet the minimum/preferred qualifications for the position. You will also be asked to provide three professional/supervisor references during the application process. References will not be contacted prior to notifying you.

Contact:

Jennifer Wilkie
jwilkie@wisc.edu
608-262-8025
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Clin Res Compl Mgr(RE106)

Department(s):

A53-MEDICAL SCHOOL/CARBONE CANC CTR/CANC CTR

Employment Class:

Academic Staff-Renewable

Job Number:

293486-AS

The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. 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/

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.

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