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11015 - Clinical Data Coordinator

This position in the IU Simon Cancer Center assists the Clinical Research Specialist(CRS)/Clinical Research Coordinator (CRC) and the Principal Investigator in the conduct and implementation of clinical research which includes data collection, data entry, follow up and preparation and maintenance of regulatory documents.

Responsibilities include:

Data Management: Extract data from source documents for study visits and follow-up visits after registration and medical history is completed by CRS/CRC. Complete paper or electronic Case Report Forms (CRFs) within 2 weeks of a subject visit. Respond to and resolve sponsor queries in a timely fashion. Contact outside health-care providers to obtain subject records and information. Maintain and update OnCore. Assist team with the creation of source document tools. Assist with preparation for monitor visits and audits.

Regulatory: Prepare initial regulatory documents and update as needed. Create and maintain regulatory binder and file regulatory documents. Route regulatory documents for signature.

Administrative: Make copies, fax and mail documents. Merge research charts. Assist with organization of research charts. File study documents and correspondence.

To be successful in this role, the candidate should be able to problem solve, have high attention to detail both written and verbal; ability to concentrate with distractions, manage several projects at once, work with deadlines, strong interpersonal and teamwork skills, be proficient in multiple software programs and ability to utilize databases.

***A cover letter along with a resume is required to be considered for this position.***

Required: Bachelor’s degree in science or health-related field from an accredited institution; or Associate’s degree in Allied Health profession plus one year patient-related or research experience; or bachelor’s degree in other fields/completion of three years college science, plus at least two years patient-related or research experience; or high school diploma plus five years patient-related experience with two years in clinical study at the TE06 level.

Indiana University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, religion, age, sex, sexual orientation or identity, national origin, disability status, or protected veteran status. This institution is also a provider of ADA services.