- Four (4) years of related work experience.
- Experience with regulations governing clinical research (CFR, GCP, HIPPA).
- Experience with statues and guidelines relevant to regulatory affairs.
- Customer service experience.
- Master's Degree (Finance, Business Administration, Management).
- Master Excel Certified.
- CRA, CCRP, CCRC.
- Four (4) years' experience in large clinical unit within academia or research administration.
- Experience using Workday/Velos.
- Organizational skills.
- Excellent written and verbal communication skills.
- Analytical/problem solving skills.
- Assisting PI with investigator-initiated studies across multiple agencies, including protocol development, reviewing consent forms, budget planning and following.
Interface with study sponsors and study team members during study start-up and maintenance regarding regulatory documents, other regulatory issues or contract modifications. Provide updates as required, escalate as appropriate. - Perform start-up activities including submission of study documents to the Institutional Review Board, maintaining timeline goals and escalating delays appropriately, collaborating with team members to ensure regulatory documents are completed and accurate. Completion and maintenance of study file documents according to requirements of ICH GCP E6 and Regulatory Agencies' guidance and standards.
- Provide assistance to study monitors during routine monitor visits or audits
- Update protocol and study information into the Clinical Trial Management System (Velos) for team collaboration.
- Support the management or perform analytical and financial activities associated with cost of studies, forecasting, planning, and managing clinical portfolios.
- Review clinical trial protocol amendments and revise amendments with principal investigators, study teams, and clinical trial contract associates. Prepare clinical trial amendment documents and memos as requested. Submit amendments to the IRB approval.
- Maintain clinical trial amendment information in appropriate database.
- Prepare study approvals for the study team once IRB approval is received. Prepare continuing review documents and work with the study team to receive
- Other duties as assigned.
- Resume/CV
- Cover Letter
-
Regulatory Coordinator
1 week ago
University of Kansas Medical Center Kansas City, United States Full timeDescription · : Required Qualifications · Education : Bachelor's Degree. Professional, related experience may be substituted for the education requirement on a year-for-year basis. · Work Experience : · Four (4) years of related work experience. · Experience with regulations ...
-
University of Kansas Medical Center Kansas City, United StatesDepartment: · SOM KC Psychiatry & Behavior Sciences · * ---- · Administration · Position Title: · Regulatory Coordinator- Psychiatry and Behavioral Sciences · Job Family Group: · Professional Staff · Job Description Summary: · This position is responsible for performing study-spe ...
-
Regulatory Affairs Coordinator
2 weeks ago
Randstad Life Sciences US Missouri, United StatesRegulatory Affairs Expert-Medical Devices · 1 Year (Temp to perm) · St Louis, MO (Hybrid 2-3 days onsite) · Pay: $33.00/hr · Your Role: · With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory tasks related to health authority notific ...
-
Corporate Counsel
1 week ago
Vermont Electric Cooperative Johnson, United StatesVermont Electric Cooperative seeks a Corporate Counsel to advise on regulatory, business law, and governance. · At VEC, we're small enough to know everyone by name and large enough to be leaders in utility innovation. As the largest electric Cooperative in Vermont, we have nonpro ...
-
FusionWorks Blue, United StatesBlue 'SITE MANAGER (M/F/D) IN THE FIELD OF ENERGY AND BUILDING TECHNOLOGY PERMANENT POSITION, FULL-TIME · HAMBURG AN EXCITING JOB. FOR EXCITING PEOPLE. At BAUER, we see collaboration as more than just good teamwork. We put our hearts into it. Honest, straightforward. We take a s ...
-
Director of Medical Surgical RN
1 week ago
NPAworldwide Kansas City, United StatesThe Director of Nursing manages the financial and clinical operations of assigned area(s) and recommends qualified competent persons to provide care. Integrates department services with the hospital's primary function. Coordinates and integrates services within departments. Devel ...
-
Outpatient Registered Nurse
6 days ago
FRESENIUS MEDICAL CENTER Kansas City, United StatesPURPOSE AND SCOPE: · The professional registered nurse Outpatient RN CAP 2 may be an entry level designation into the Clinical Advancement Program (CAP) for new employees who meet the RN CAP 2 criteria or attained through advancement from RN CAP 1. This position is accountable an ...
-
Medical Lab Scientist Tech Specialist
1 week ago
The University of Kansas Hospital Kansas City, United StatesPosition Title · Medical Lab Scientist Tech Specialist · Bell Hospital · Position Summary / Career Interest: · The MLS Technical Specialist participates in all departmental responsibilities for comprehensive laboratory testing for patients. This includes ensuring patients laborat ...
-
Warehouse Director
23 hours ago
SYSCO Olathe, United States Full timeCompany: · US0057 Sysco Kansas City, Inc.Zip Code: · 66061Minimum Level of Education: · Bachelor's DegreeMinimum Years of Experience: · 7 YearsEmployment Type: · Full TimeTravel Percentage: · Up to 25%COMPENSATION INFORMATION: · The pay range provided is not indicative of Sysco ...
-
Safety & Training Coordinator
1 week ago
Harcros Chemicals Kansas City, United StatesSafety & Training Coordinator · Summary: · Harcros Chemicals Inc. is an employee-owned company celebrating over 100 years of continuous operations in specialty chemical manufacturing and distribution. We currently have 3 manufacturing plants and 26 distribution facilities in 20 s ...
-
Mechanical Design Engineer
1 week ago
Career Collective Kansas City, United StatesJob description · Essential Duties and Responsibilities: · Expanding the company's engineering breadth and growing and maintaining client relationships · Collects and prepares data/information and performs engineering calculations. · Responsible for the production of CAD drawings ...
-
Point of Care Coordinator
3 days ago
The University of Kansas Health System Kansas City, United StatesPosition Title · Point of Care Coordinator · Days - Full Time · Bell Hospital · Position Summary / Career Interest: · The Laboratory Point of Care Coordinator, POCC, collaborates with the laboratory leaders, laboratory medical director, hospital and laboratory quality teams, ...
-
Point of Care Coordinator
1 week ago
The University of Kansas Health System Kansas City, United StatesPosition TitlePoint of Care CoordinatorDays - Full TimeBell HospitalPosition Summary / Career Interest:The Laboratory Point of Care Coordinator, POCC, collaborates with the laboratory leaders, laboratory medical director, hospital and laboratory quality teams, nursing and other l ...
-
Manager of Case Management
3 days ago
Wyandot Behavioral Health Network, Inc. Kansas City, United StatesWyandot BHN is seeking a dedicated *Manager of Case Management *to be responsible for the overall supervision of our adult case management team The Manager of Case Management will assist team members to provide exceptional service to adults and families by achieving all agency st ...
-
Histology Technical Specialist
1 week ago
The University of Kansas Hospital Kansas City, United StatesPosition Title · Histology Technical Specialist · Bell Hospital · Position Summary / Career Interest: · The Histology Technical Specialist will perform all routine histologic procedures including: 1) · Grossing/Fixation, 2) Processing, 3) Embedding, 4) Sectioning, 5) Staining, an ...
-
Credentialing Coordinator
1 week ago
The University of Kansas Health System Kansas City, United StatesPosition Title · Credentialing Coordinator · Bell Hospital, Broadmoor Campus · Position Summary / Career Interest: · Coordinates the credentialing and onboarding of physicians and allied health providers for professional staff membership and health system privileges. Provides ...
-
Patient Meal Preparer
1 week ago
The University of Kansas Health System Kansas City, United StatesPosition Title · Patient Meal Preparer · Strawberry Hill Campus · Position Summary / Career Interest: · Under the direction of the Supervisor this position is responsible for preparing meals for patients, visitors and employees. The position will also clean and sanitize work stat ...
-
Quality Outcomes Coordinator
1 week ago
The University of Kansas Health System Kansas City, United StatesPosition Title · Quality Outcomes Coordinator · Days - Full Time · Wescoe Pavilion C · Position Summary / Career Interest: · Under the supervision of the Quality Outcomes Nurse Manager and in conjunction with Nursing Leadership, the Quality Outcomes Coordinator implements an ...
-
Quality Outcomes Coordinator
3 days ago
The University of Kansas Health System Kansas City, United StatesPosition Title · Quality Outcomes Coordinator · Days - Full Time · Wescoe Pavilion C · Position Summary / Career Interest: · Under the supervision of the Quality Outcomes Nurse Manager and in conjunction with Nursing Leadership, the Quality Outcomes Coordinator implements an ...
-
Scale Operator- Cheyenne
1 week ago
Nucor Harris Rebar Kansas City, United StatesNucor is North America's largest recycler and most diversified steel and steel products company. Since 1969, we've led the industry in developing innovative technologies for recycling scrap into high-quality steels that are all around us, from bridges and buildings to cars and ap ...
Regulatory Coordinator - Kansas City, United States - University of Kansas Medical Center
Description
Department:SOM KC Neurology
Administrative ServicesPosition Title:
Regulatory CoordinatorJob Family Group:
Professional StaffJob Description Summary:
The Department of Neurology is seeking a Regulatory Clinical Trials Coordinator to support and manage complex clinical research portfolio in collaboration with our institutional structures, faculty, and sponsors. This position provides a full range of administrative support for the clinical research enterprise in the Neurology Department with primary emphasis in ensuring the adequate support to Neurology faculty while strategically outlining resources for the development of clinical research in accordance with institutional, federal, state, or other extramural sponsors policies and guidelines. Key responsibilities leading and performing study-specific regulatory, safety reporting, and quality improvement activities, and fiscal management in support of clinical research enterprise within the Department of Neurology.
Serves as the administrative resource and liaison involved in supporting the business aspects of the clinical research enterprise. Function encompasses activities related to the full life cycle of clinical research administration and overall compliance with university policies, state and granting sponsoring agency. This position is responsible for leading and performing study-specific regulatory and study- specific regulatory and safety reporting for a group of investigators, within multiple cost centers in the Department of Neurology. Responsible to ensure the research is compliant with applicable federal, state or international requirements, while adhering to policies of the University of Kansas Medical Center. Assigned contact for study-start up activities including IRB/Ancillary committee submissions, and maintenance of regulatory records throughout the life project for assigned cost centers.
The successful candidate should have superior organizational skills, excellent leadership qualities, and be able to efficiently manage competing priorities. In addition, they will be able to operate with autonomy, evaluate and prioritize responsibilities and build strong relationships with stakeholders under limited oversight from Manager.Job Description:
Required Qualifications
Education: Bachelor's Degree. Professional, related experience may be substituted for the education requirement on a year-for-year basis.
Work Experience:
Education/Certification:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus nine paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.
Employee Type:
RegularTime Type:
Full timeRate Type:
Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:
$54, $80,000.00
Minimum
$54,000.00
Midpoint
$67,000.00
Maximum
$80,000.00
