Research Regulatory Assistant III - 100% Remote

Position Description:

Every great life-changing discovery begins the same way-with new knowledge. It can change everything, from a single life to the future of entire communities. That's why academic medicine, and the continuous pursuit of knowledge, is at the center of everything we do at the Medical College of Wisconsin (MCW). In the role of a Research Regulatory Assistant III you will be working in our Center for Cancer Discovery.

Purpose

Assist regulatory staff and clinical teams by providing administrative and regulatory support for clinical research regulatory team.

Primary Functions

• Under direction of the CTO regulatory manger, clincal research managers, study coordinators/regulatory specialists, collect documents and assist with submission and post-approvals of amendments and continuing progress reports. Contact study team members to obtain required information.
• Organize study charts and files, and distribute to appropriate location.
• Coordinate research regulatory projects such as mailings including doctor to doctor letters.
• Accurately enter regulatory data (for example staff updates and post approval information onto reports or specified programs (OnCore) and other databases as appropriate under the direction of the regulatory specialist or study coordinator
• Prepare or assist with preparation of individual NCI packets for Cancer Center investigators on annual basis. Proactivley manage to prevent lapse in investigator status.
• Assist with triage of phone calls and emails coming to clinical trials office from MCW or Froedtert website or NIH Clinicaltrials.gov website.
• Prepare communications and mailings as requested by regulatory team.
• Maintain research regulatory staff supplies and ensure a safe, organized and functional research work space. Other duties as assigned.

Knowledge - Skills - Abilities

Preferred Schedule:



8:00-4:30 Monday - Friday

Position Requirements:

Specifications

Appropriate experience may be substituted for education on an equivalent basis

Minimum Required Education: High School Diploma

Minimum Required Experience: 3 years

Preferred Experience: 3 years of related experience, 2 of which consists of clinical research study

support.

Certification: CITI training within 90 days of hire

Target salary range for this position is between $48,700.00 and $60,000.00 annually. The final offered salary will depend on the applicant's education, experience, skills, and knowledge, as well as considerations of internal equity and market alignment.

Why MCW?

• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• Paid Parental Leave
• Pet Insurance
• On campus Fitness Facility, offering onsite classes.
• Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

For a full list of positions see: www.mcw.edu/careers

For a brief overview of our benefits see: https://www.mcw.edu/departments/human-resources/benefits

At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring - Collaborative - Curiosity - Inclusive - Integrity - Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you.

MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination


The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants, or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.

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