Regulatory Coordinator

University of Wisconsin Madison; Brantford; Hybrid; USD 51,000 - 70,000; Full time

Job summary

An established academic institution is seeking a Regulatory Coordinator to oversee compliance for clinical trials. This role involves preparing regulatory documents, ensuring adherence to protocols, and providing guidance to research teams. The ideal candidate will thrive in a dynamic environment, balancing multiple tasks while maintaining attention to detail. Join a collaborative team dedicated to advancing research and improving patient outcomes. This position offers a chance to make a significant impact in the field of clinical research while enjoying a supportive workplace culture focused on diversity and inclusion.

Benefits

Generous vacation

Competitive insurances

Retirement benefits

Qualifications

• Regulatory experience in Human Subject research is essential.
• Strong written communication skills and attention to detail are required.

Responsibilities

• Provides regulatory support for research studies and ensures compliance.
• Develops and submits protocol-specific application materials.

Skills

Regulatory experience with Human Subject research

Patient care research visits

Attention to detail

Strong written communication skills

Ability to meet deadlines

Education

Bachelor's of Science in biology or health related field

Job description

Job Summary:

The Regulatory Coordinator completes and maintains regulatory documents for clinical trials to ensure protocol, regulatory and Standard Operating Procedures (SOP's) and Good Clinical Practice (GCP) compliance. They will assist the Manager and Supervisor of the unit and train coordinating staff as delegated by the manager. The position requires strong written communications skills, attention to detail, ability to meet multiple and changing deadlines, the ability to interact with a variety of people and to consult numerous sources for information for preparation of documents and assist with responses to IRB and sponsor questions that are compatible with numerous policies and procedures. This position is also responsible for maintaining regulatory compliance guidelines for each trial and educating CERU staff in sponsor guidelines. The incumbent must be able to work in a very busy interactive environment with frequent interruptions and to perform tasks accurately in a timely fashion. This position will also include study coordinator duties as time permits which would involve recruiting, screening, assisting in determining eligibility, enrolling study participants, and conducting with a strong focus on teamwork.

Responsibilities:
Provides regulatory support for research studies. Assists in all regulatory activities including reviewing documents, applications, and reports, and ensuring compliance with the internal and external regulatory framework. Ensures compliance with all regulations, laws, and research standards pertaining to research. Applies skills to a broad range of different types of studies, navigates resources, and identifies issues needing escalation. Performs quality checks and may train staff. Contributes to the development of new team and unit processes, procedures, tools, and training.

• 25% Develops, prepares, and submits protocol-specific application materials to regulatory bodies such as the Institutional Review Board and scientific review committee


• 10% Develops clear and accurate informed consent documents


• 10% Maintains complete and accurate regulatory files and records


• 10% Communicates directly with protocol sponsors related to regulatory documents and activities


• 5% Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations


• 10% Performs quality checks


• 5% May lead and train other staff


• 5% Contributes to the development of new team and unit processes, procedures, tools, and training


• 20% Study coordination, recruits, screens, selects, determines eligibility, enrolls trial participants, collects complex info, performs medical assessments, answers varied questions under supervision of a medical professional. Performs med assessments.

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 of Science in biology or health related field.

Qualifications:

Required:
-Regulatory experience with emphasis on Human Subject research
-Experience with patient care research visits

Preferred:
-Ophthalmology experience preferred.
-Quality assurance experience preferred

License/Certification:

Preferred
Certified Clinical Research Coordinator (CCRC) certification preferred.

Work Type:

Full or Part Time: 80% - 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 $51,955 ANNUAL (12 months)
Depending on Qualifications
Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (https://hr.wisc.edu/benefits/).

Additional Information:

University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous 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 the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position you must provide proof of work authorization and eligibility to work.

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 and experience, and a document listing contact information for three (3) references, including your current/most recent supervisor. References will not be contacted without prior notice.

Contact:

Beth Reuter
[e-mail]
608-263-3680
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Regulatory Coordinator(CP085)

Department(s):

A53-MEDICAL SCHOOL/OPHTHAL&VIS SCI/GEN

Employment Class:

Academic Staff-Renewable

Job Number:

314060-AS

The University of Wisconsin-Madison is an Equal Opportunity 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 by acknowledging skills and expertise from all diverse backgrounds and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, click here

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 may require a criminal background check. It may 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.