Quality Control Specialist

Vodafone; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Indiana University is seeking a Research Compliance Coordinator to manage clinical trials at the IUSCCC. The successful candidate will develop project plans, ensure compliance with regulations, and collaborate with stakeholders. This position requires a Bachelor's degree and 3 years of related experience in a healthcare setting, emphasizing analytical and organizational skills.

Benefits

Comprehensive medical and dental insurance

Health savings account with contributions

Voluntary supplemental life and disability insurance

Tuition subsidy for employees and family members

Generous paid time off plans

Employee assistance program (EAP)

Qualifications

• 3 years of relevant work experience in a sponsored research, compliance, healthcare, or clinical setting.
• Demonstrated ability to maintain confidential information.

Responsibilities

• Develops and implements moderately complex project plans for research compliance.
• Manages project plans including documentation maintenance and training.
• Collaborates with research stakeholders to identify and mitigate compliance gaps.

Skills

Analytical skills

Organizational skills

Written communication

Verbal communication

Judgment and decision making

Collaboration

Education

Bachelor's degree in business, health services, or related field

Job description

The mission of the Indiana University Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCCC translational clinical investigators. The CTO is a centralized resource available to all clinical investigators of the IUSCCC whose services enable the safe and efficient conduct of adult and pediatric trials. The CTO provides a comprehensive range of services. These services begin in the early stages of protocol development and continue throughout the study implementation, publication and long-term follow-up.
As the state's premier urban research institution, IU Indianapolis is committed to being a welcoming campus community and we seek candidates whose research, teaching, and community engagement efforts contribute to robust learning and working environments for all students, staff, and faculty.

Job Summary

• Develops and implements moderately complex project plans consistent with the requirements of current and new federal, state, and local regulations and statutes as well as the compliance policies of the University.
• Manages implemented project plans including maintenance of program documentation, performance of training, monitoring and auditing.
• Collaborates with key research and operational stakeholders at IU to identify research compliance gaps, find solutions to mitigate risks and implement project plans.
• Continuously monitors regulatory changes and determine impact on research community.
• Collaborates with the research community to disseminate information and develop solutions to address regulatory requirements and contribute to compliance decision making.
• Expands knowledge by managing and participating in various committee meetings and attending workshops and conferences.

Qualifications

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

EDUCATION
Required

• Bachelor's degree (preferably in business, health services, or related field)

WORK EXPERIENCE
Required

• 3 years of relevant work experience in a sponsored research, compliance, healthcare, or clinical setting

SKILLS
Required

• Demonstrated ability to maintain confidential information
• Demonstrated analytical skills
• Excellent organizational skills
• Proficient written and verbal communication skills
• Demonstrates excellent judgment and decision making skills
• Experience in a regulated environment
• Excellent collaboration and team building skills
• Maintains composure under pressure
• Ability to work within tight time frames and meet strict deadlines

Working Conditions / Demands

This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation.

Work Location

IUSCCC Clinical Trials Office
IU Indianapolis
Indianapolis, Indiana

Benefits Overview

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
• Base retirement plan with generous IU contributions, subject to vesting
• Voluntary supplemental retirement plan options
• Tuition subsidy for employees and family members taking IU courses
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)

Learn more about our benefits by reviewing the IU Benefit Programs Brochure .

Job Classification

Career Level: Career
FLSA: Exempt
Job Function: Research
Job Family: Research Compliance
Click here to learn more about Indiana University's Job Framework.

Posting Disclaimer

This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.

Equal Employment Opportunity

Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information .

Campus Safety and Security

The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at [e-mail] or by visiting IUPD.