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HCRN seeks research safety manager

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Hoosier Cancer Research Network (HCRN) currently seeks a full-time research safety manager to join our team. One year of experience in clinical research administration is required.

HCRN is an independent nonprofit contract research organization based in Indianapolis, Ind., that specializes in early phase, multi-center, investigator-initiated oncology trials. Our studies are conducted through a nationwide network of more than 450 academic and community sites.

Job Description
  • Reviews incoming SAE documents for completeness and clarity and communicates with the submitting site to resolve any documentation issues with SAE report.
  • Summarizes SAE information for the Sponsor Investigator to allow him/her to assess the expectedness of the event and relationship of event to study drug(s).
  • Communicates SAE information to funder per protocol guidelines and/or study-specific Safety Management Plan.
  • Creates MedWatch Report form and notifies appropriate authorities per FDA Reporting guidelines and protocol/funder specific requirements.
  • Records and maintains SAE log sheet (Excel document) to capture all Serious Adverse Events specific to protocol.
  • Distributes MedWatch reports to HCRN sites via email correspondence.
  • Receives and processes all IND Safety letters.
  • Maintains and updates IND Safety Report Summary spreadsheet (Excel spreadsheet).
  • Uploads all IND Safety Letters into OnCore database within appropriate protocol(s).
  • Reviews new protocols in development stage for accurate safety language and processes to ensure consistency with HCRN safety SOPs.
  • Communicates with HCRN protocol development regarding SAE reports reviewed by Sponsor Investigator and whether an amendment to the protocol and/or consent was identified by the sponsor-investigator.
  • Communicates with HCRN personnel when updated Investigator’s Brochures (IBs) are received to ensure all applicable parties are aware and triggering the IB review by HCRN protocol development.
  • Other duties as assigned.

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. Usually, normal office working conditions. The noise level in the work environment is usually quiet to moderate noise level.

Job Type: Full-time

No calls or walk-ins, please.

Hoosier Cancer Research Network is an equal opportunity employer.

To apply, see our job post on Indeed.

 

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. 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 conducted more than 230 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 9,000 subjects have participated in Hoosier Cancer Research Network clinical trials.