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HCRN seeks regulatory and safety associate

Hoosier Cancer Research Network (HCRN), a nonprofit cancer research organization in Indianapolis, is currently seeking a full-time Clinical Research Regulatory and Safety Associate.

Job Description:

Collection and processing of regulatory and serious adverse event (SAE) related documentation for multi-site, investigator-sponsored oncology clinical research studies. Duties and responsibilities include, but are not limited to:

  • collection and tracking of essential regulatory documents
  • coordination of initial submission and maintenance of INDs
  • review and approve site specific informed consent documents
  • serve as central point of contact for expedited serious adverse event reporting including report review, querying, tracking, and distribution
  • process and track outside safety reports from drug manufacturers
  • maintain regulatory and SAE related portions of trial master files as well as study management software

Job Type: Full-time

Job Location: Indianapolis, IN (not remote)

Required education: Associate

Required experience: Clinical Trial Regulatory (2 years)

Language Skills:

  • Ability to read and interpret documents such as computer software and documentation and procedure manuals. Will have the ability to write routine reports and business correspondence.

Reasoning Ability:

  • Ability to solve practical problems and deal with a variety of concrete issues. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

Physical Demands:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to sit and use hands to use a computer. The employee is occasionally required to reach with hands and arms for supplies. Specific vision abilities required by this job include close vision, and ability to adjust focus when using a computer.

Mental Demands:

  • The mental demands represent those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Mental demands represent high attention to detail (both written and verbal), managing multiple concurrent tasks, working with deadlines, personal initiatives.

Work Environment:

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 

Applicants should send resumes by email to Christy Yoder at cyoder@hoosiercancer.org with “Clinical Research Regulatory and Safety Associate” in the subject line.

No calls or walk-ins, please.

Hoosier Cancer Research Network is an equal opportunity employer.

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in partnership with academic and community physicians and scientists across the United States and internationally. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has initiated more than 160 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 5,000 subjects have participated in Hoosier Cancer Research Network clinical trials.