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HCRN seeks protocol development coordinator

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Hoosier Cancer Research Network (HCRN) currently seeks a full-time protocol development coordinator to join our team. Bachelor’s degree in a health science field and at least two years of experience and certification (e.g., SoCRA, ACRP, etc.) in clinical research preferred.

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

  • Will be the liaison between physicians and pharmaceutical partners to assist with streamlined letter of intent (LOI) submissions.
  • Track incoming LOI submissions and work with lead physician to meet deadlines
  • Review LOI submission requirements and work with lead physician/HCRN staff to obtain necessary information
  • Manage study development tracking system and enters protocol details and development milestones in study tracking system.
  • Work collaboratively with HCRN team to obtain initial budget for LOI
  • Submit completed LOI to appropriate funder portal
  • Attend Clinical Trial Working Group (CTWG) teleconference calls. Occasional opportunity to travel for face to face meetings with Investigators and/or Pharmaceutical Partners
  • Initiate clinicaltrials.gov postings for Hoosier Cancer Research Network (HCRN) clinical trials and maintain updates to the website during the lifecycle of the trial
  • Prepare first draft of informed consent template for research development directors
  • Review new HCRN clinical trial protocols to ensure clarity and internal consistency
  • Track key data on Patient Reported Outcome Tools used in HCRN clinical trials and assist in obtaining for a specific trial
  • Develop and maintain a process for ensuring HCRN has current Investigator Brochures on file
  • Work collaboratively with HCRN data team during electronic database builds.
  • Annual review or development of process documents specific to protocol development
  • Amendments to protocol and consent during life of the trial; includes drafting associated summary of changes
  • Annual review and update of template documents; protocol, ICF, summary of changes, etc.
  • Other projects as assigned by research development director

EDUCATIONAL REQUIREMENTS:

  • Bachelor’s degree in a health science field. At least two years of experience and certification (e.g., SoCRA, ACRP, etc.) in clinical research preferred.

LANGUAGE SKILLS:

  • Ability to read and interpret documents and procedure manuals, including drug brochures.
  • Ability to write routine process documents.
  • Ability to navigate websites and electronic document storage files.
  • Knowledge of computer programs such as Word, Excel, and Power Point.
  • Ability to effectively communicate with various audiences within and external to Hoosier Cancer Research Network, Inc.

REASONING ABILITY:

  • Ability to solve practical problems and deal with multiple channels of input.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Ability to prioritize multiple projects in various stages of completion

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.

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.