Multicenter Project Manager (Quality Control Specialist)
Indiana University

Department

CANCER CENTER (IN-CANC-IUINA)

Department Information

The mission of the IU 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.

Job Summary

The multicenter research team is responsible for opening oncology clinical research trials at sites across the state, nationally, and internationally.

Department-Specific Responsibilities

• Manages participating sites and responsibilities including study planning, staff education, regulatory, monitoring and auditing, logistics, and study close-out.
• Manages start-up and preparation including the creation of all study materials/documents and opening participating sites.
• Oversees logistical responsibilities of contracts, budgets, invoicing, samples collection, processing, and storage.
• Manages regulatory documents, conducts site training, confirms eligibility of study subjects, and serves as the main point of contact for participating sites and funding agencies.
• Assesses accuracy and completeness of data completion and other trial-related records; ensures protocol compliance and adherence to policies and regulations.
• Manages regular calls with lead and participating sites.
• Conducts study close out with all participating parties.

General Responsibilities

• 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

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

Combinations of related education and experience may be considered

SKILLS

Required

• Demonstrated ability to maintain confidential information
• Demonstrated analytical skills
• Excellent organizational skills
• Proficient 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.

Additional Information

This position may be eligible for a sign on bonus.

Work Location

IUSCCC Clinical Trials Office

IUPUI Campus

Indianapolis, Indiana

Benefits Overview

Indiana University offers a wide array of benefits including:

• Multiple plan options for medical insurance
• Dental insurance
• Health Savings Account with generous IU contribution
• Life insurance, LTD, and AD&D options
• Base retirement plan contribution from IU
• Additional supplemental retirement plan options
• Tuition benefit for IU classes
• 10 paid holidays per year
• Generous Paid Time Off
• Paid Parental Leave

Learn more about our benefits by reviewing our online Benefits 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

Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.

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.

New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page.

Equal Employment Opportunity

Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's 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 iups@iu.edu or by visiting IUPD.

Contact Us

Request Support
Telephone: 812-856-1234

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