Assistant Data Manager (Clinical Research Coordinator)

CANCER CENTER (IN-CANC-IUINA)

The IU Simon Comprehensive Cancer Center (IUSCCC) is 1 of only 57 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 Biospecimen Collection and Banking Core (BC²) supports cancer research by providing comprehensive biospecimen management including collection, storage, distribution, and annotation.

Department-Specific Responsibilities

• Provides direct management to the BC² data annotation team.
• Assists in data capture for large oncology dataset.
• Supports data quality and integrity assessments and develops strategies for supporting ongoing data quality and integrity.
• Evaluates data procurement strategies to streamline data annotation efforts.
• Provides routine data updates to BC² end users.
  
  

General Responsibilities

• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
• Participates in study budget negotiations and reconciles study budget accounts.
• Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
• Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
• Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
• Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.)
• Reviews incoming subject adverse event (SAE) information, assists Principal Investigator (PI) in making submission determination of SAEs, and follows up to determine resolution of adverse events.
• Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
• Stays up to date with knowledge of regulatory affairs and/or issues.
  
  

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.

Required

EDUCATION / WORK EXPERIENCE

• Bachelor's degree in science or a health-related field and 2 years of clinical research experience; OR
• Associate's degree in science or a health-related field and 3 years of clinical research experience
  
  

Preferred

• Management experience
  
  

LICENSES AND CERTIFICATES

Preferred

• SOCRA/ARCP Clinical Research Certification upon date of hire
• National Cancer Registrar's Association Oncology Data Specialist (ODS) Certification
  
  

Skills

Required

• Demonstrated analytical skills
• Ability to simultaneously handle multiple priorities
• Possesses strong technical aptitude
• Demonstrates a high commitment to quality
• Excellent organizational skills
  
  

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.

Indianapolis, Indiana

IU - Indianapolis campus

This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.

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.

Career Level: Career

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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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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