Indianapolis, IN

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 Oncology Statewide Research Administrator will provide operational leadership for all clinical trial operations located outside of the downtown IU Simon Comprehensive Cancer Center location. Currently, this position will be responsible for clinical research operations at IU Health North Schwarz Cancer Center and IU Health West.

Department-Specific Responsibilities

• Responsible for clinical trial feasibility review, hiring, training, performance management, quality assurance to include new policy and procedure development, compliance, data management, documentation, and reporting of cancer center metrics.
• Serves as a liaison between the CTO, sponsors, IU Health Schwarz and West leadership and principal investigators.
• Oversees new locations that participate in IUSCCC oncology clinical trials.

General Responsibilities

• Provides highest level of operational leadership and coordination of assigned staff members for clinical research operations and activities; provides direction and guidance on high priority and/or complex clinical research projects/initiatives.
• Conducts a variety of personnel actions to include, but not limited to hiring, training, promotion, performance management, and dismissal.
• Develops and educates on departmental policies and procedures to ensure the efficient operation of both clinical trials and related patient care; establishes standard operating procedures for clinical research operations/activities and ensures compliance with all internal and external requirements of regulatory agencies.
• Evaluates protocol, study design, and assesses risk to subject population.
• Manages staff assignments and allocation of clinical research resources, including determining staff and facility availability; assesses study population/availability; reviews and critically evaluates study contract(s)/letter(s) of agreement.
• Prepares and negotiates budget; prepares payment schedule with sponsor(s); negotiates fees for associated services; manages study account(s) and ensures that expenditures do not exceed contracted amount and are appropriate/approved.
• Oversees and establishes processes/procedures for the proper screening of study subjects; ensures that Informed Consent forms are explained to study participants and all required signatures are obtained prior to start of study.
• Establishes, implements, and ensures quality assurance for clinical research operations; seeks peer-review for quality assurance practices that retrospectively evaluates accuracy and timeliness of study completion and/or identifies potential protocol violations.
• Communicates with sponsors concerning progress of clinical research, budgetary updates, patient study-related problems or concerns, recruitment strategies and specific policies and procedures.
• Acts as liaison between clinical research staff and study sponsors, IRB, federal, state and university officials and other regulatory agencies to maintain regular communication of costs, policy changes, fiscal requirements, and other regulatory issues.
• Serves as representative and advisor for clinical research operations on appropriate university committees, work groups and task forces.
• Researches and stays up-to-date with new research developments by attending continuing education meetings, lectures, training sessions and/or conferences.

Qualifications

EDUCATION / WORK EXPERIENCE

Required

• Master's degree plus 2 years in clinical research, including supervisory experience OR
• Bachelor's degree in science or health-related field plus 4 years of experience in clinical research, including supervisory experience OR
• Associate's degree in Allied Health plus 5 years of experience in clinical research, including supervisory experience

Combinations of related education and experience may be considered

LICENSES AND CERTIFICATES

Required

• ACRP or SOCRA clinical research certification upon date of hire

SKILLS

Required

• Proficient communication skills
• Maintains a high degree of professionalism
• Demonstrates time management and priority setting skills
• Demonstrates a high commitment to quality
• Excellent organizational skills
• Excellent collaboration and team building skills
• Effectively coaches and delivers constructive feedback
• Instills commitment to organizational goals
• Demonstrates excellent judgment and decision making skills
• Effective conflict management skills
• Builds and manages effective teams

Working Conditions / Demands

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.

Work Location

IUSCCC Clinical Trials Office

IUPUI Campus

Indianapolis, Indiana

Job Classification

Career Level: Sr. Operational

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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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.

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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.

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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.

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