Data & Safety Monitor (Quality Control Specialist) Details

Data & Safety Monitor (Quality Control Specialist)

Indiana University - Indianapolis, IN

Employment Type : Full-Time

Department

CANCER CENTER (IN-CANC-IUINA)

The IU Simon Comprehensive Cancer Center (IUSCCC) is one of only 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the United States. This prestigious designation recognizes centers around the country that meet rigorous criteria for world-class, state-of-the-art programs in multidisciplinary research. The IUSCCC puts significant resources into developing research programs, faculty, and facilities that will lead to better approaches to prevention, diagnosis, and treatment of cancer.

The IU Simon Comprehensive Cancer Center is seeking a Data and Safety Monitor to conduct safety and data monitoring for early phase investigator-initiated trials (ITTs). This role will ensure appropriate documentation of clinical trial eligibility, treatment administration, and adverse event (both serious and non-serious), as well as data collection consistent with protocol requirements. All monitoring will take place on site at the IUSCCC and will adhere to the risk-based monitoring strategy. This role is ideal for someone who is passionate about cancer research, patient safety, data integrity, and is familiar with electronic medical records (e.g., Cerner) and clinical trial management systems (e.g., Oncore).

Department Specific Responsibilities

• Participates in ongoing data monitoring and validation to ensure timely dose escalation decisions for enrolling IITs.
• Ensures source verification for clinical trial eligibility, treatment administration, and toxicity collection, including review for potential reportable events.
• Ensures accuracy and completeness of adverse event and serious adverse event collection for clinical trial participants, including detailed review for dose limiting toxicities.
• Manages assigned hematology/oncology clinical trials by tracking enrollment, setting up routine monitor visits, and generating/resolving data queries within the Oncore Clinical Trial Management System (CTMS) to meet the IUSCCC Data and Safety Monitoring Plan (DSMP) risk-based monitoring requirements.
• Educates study team members regarding the appropriate data collection in order to minimize recurring queries.
• Independently manages schedule of monitoring visits and maintain appropriate documentation of monitor visits, follow up, and action plans.
• Serves as the initial point of contact for the Compliance Team regarding the data quality assurance and overall compliance of assigned trials.
• Prepares summary reports for assigned studies for Data and Safety Monitoring Committee (DSMC) review.
• Contributes to the development of Compliance Team SOPs with regard to monitoring, auditing and DSMC reviews as needed.

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 determines 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.

EDUCATION

Required

• Bachelor's degree

Preferred

• Degree 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

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.

This position may be eligible for a sign-on bonus.

IUPUI Campus

Indianapolis, Indiana

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.

Career Level: Career

FLSA: Exempt

Job Function: Research

Job Family: Research Compliance

Click here to learn more about Indiana University's Job Framework.

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.

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.

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.

Request Support
Telephone: 812-856-1234