Clinical Research Quality Assurance Specialist II

Davita Inc.; Milwaukee (WI); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading healthcare institution is seeking a Clinical Research Quality Assurance Specialist II. You will oversee complex clinical research studies, ensuring compliance with regulations and guidelines. This role involves developing procedures and providing training to clinical research teams. Offering robust benefits including health coverage, retirement plans, and tuition reimbursement.

Benefits

Outstanding Healthcare Coverage

403B Retirement Package

Competitive Vacation and Paid Holidays

Tuition Reimbursement

Paid Parental Leave

Pet Insurance

Fitness Facility On Campus

Discounts on local services

Qualifications

• Minimum 4 years of experience required.
• CITI training certification within 90 days of hire is necessary.
• Experience in Clinical Research Coordination preferred.

Responsibilities

• Oversee clinical research study protocols for compliance and quality.
• Develop departmental policies and educational materials.
• Work with teams to resolve non-compliance issues.

Skills

Critical Thinking

Problem Solving

Communication Skills

Education

Bachelor's degree

Job description

Position Description:

The Medical College of Wisconsin (MCW) brings a synergy between the best medical education, research and patient care. Tomorrow's discoveries happen right here alongside the very people who bring those lessons to our students. Every bit of knowledge, and every advancement, provides our students with an unprecedented, collaborative learning environment, and helps improve the vitality and care of our communities. In the role ofa Clinical Research Quality Assurance Specialist IIyou will beworking in our Cancer Center.

Purpose

Under general supervision the Clinical Research Quality Assurance Specialist II is responsible for the oversight of clinical research study protocols of increasing complexity, with an emphasis on quality, training, monitoring, and the development of tools for study team use. The Clinical Research Quality Assurance Specialist II will assist in logistical and operational feasibility assessments, coordinate the implementation of research projects and the day-to-day administrative activities of the program and will provide support to teams to facilitate the achievement of the program's goals.

Primary Functions

• Perform quality assurance and oversight of research protocols of higher complexity.
• Use advancing knowledge to develop and disseminate clinical research education as needed in accordance with federal regulations, institutional policies, and specific protocol requirements.
• Develop departmental policies, procedures, and guidelines.
• Apply knowledge of clinical research to provide recommendations and direction to clinical research teams to ensure compliance.
• Conduct meetings to disseminate quality assurance findings.
• Work with teams to resolve clinical research non-compliance through root cause analysis, corrective, and preventative action plans
• Assist with the development and implementation of processes to ensure efficiencies between the CTO and collaborating departments. Utilize CTO quality improvement tools & process control to facilitate improvement of systems & processes.

Knowledge - Skills - Abilities

Fundamental knowledge of FDA regulations, ICH GCP, institutional and departmental policies and proceduresData utilization, complex problem solving, critical thinking, resource management, communication and writing skills.

#LI-AV1

Preferred Schedule:




Fulltime 8:00-4:30

Position Requirements:

Specifications Appropriate experience may be substituted for education on equivalent basis Minimum Required Education: Bachelors degree Minimum Required Experience: 4 Years Preferred Experience: Clinical Research Coordination Field: Related scientific field Certification: CITI training within 90 days of hire 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 a diverse 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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