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hcrn clinical research monitor

1 week ago

Indianapolis, Indiana, United States Hoosier Cancer Research Network Inc Full time
Job Description Job Description Description:

Hoosier Cancer Research Network (HCRN) is an independent nonprofit organization with a network of clinical sites created for the purpose of conducting oncology studies. We serve as the contract research organization for early phase, multi-center, investigator-initiated clinical trials developed by investigators within its network. We collaborate with 450+ academic and community clinical research sites across the United States to develop and conduct innovative cancer research. Through our work, HCRN advances cancer research, education, and patient advocacy.

Overview

As a Clinical Research Monitor you will play a key role in evaluating the compliance and quality of clinical trials across various stages of development. You will conduct monitoring activities to ensure that clinical research activities adhere to regulatory requirements, sponsor guidelines, and Good Clinical Practice (GCP) standards. Your expertise will help identify areas for improvement, ensure data integrity, and ensure overall success of clinical trials.

Key Responsibilities

Clinical Monitoring Coordination

  • Coordinate all aspects of the clinical monitoring process in accordance with Federal Regulations, Good Clinical Practice (GCP), NCI and HCRN Standard Operating Procedures (SOPs).
  • Monitor clinical trials in accordance with HCRN's Data Safety Oversight Process (DSOP).

Site Qualification and Visits

  • Conduct site visits for new site membership into the HCRN network and evaluate qualifications to initiate clinical trials.
  • Travel to HCRN sites in accordance with the DSOP for each trial.

Reporting and Documentation

  • Prepare and submit comprehensive monitoring reports in HCRN's Electronic Data Capture (EDC) system following each site visit.
  • Communication and Problem-Solving
  • Consult with HCRN staff, site study coordinators and principal investigators to address site-level issues and facilitate effective communication.
  • Identify, troubleshoot, and resolve challenges related to protocol implementation and execution.

Data Review and Training

  • Assess data collection processes for accuracy and completeness to ensure high-quality data.
  • Provide training and guidance to clinical research personnel at sites on protocol procedures and best practices for implementation.

Regulatory Compliance

  • Review and address regulatory issues to ensure adherence to applicable standards and maintain accountability.
  • Verify the proper storage and documentation of clinical trial materials (CTM) to ensure compliance with regulatory requirements.
Requirements:
  • Bachelor's degree in life sciences or a related field; with a minimum of two years' experience in clinical research (oncology preferred), familiarity with GCP, HIPAA, medical terminology, electronic medical records, and research compliance.
  • Willingness to travel regularly to various clinical trial sites, often requiring overnight stays.
  • Excellent organizational skills with a keen attention to detail.
  • Ability to work independently and manage multiple priorities in a fast-paced environment.
  • Ability to read and interpret documents presented in written, oral, diagram or schedule form including trial documentation and procedure manuals.
  • Strong written and oral communication skills to author routine reports and business correspondence.
  • Ability to solve practical problems and deal with a variety of concrete issues.

Physical and Mental Demands

  • 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 represent high attention to detail (both written and verbal), managing multiple concurrent tasks, working with deadlines, and personal initiatives.

Work Environment

  • Reports to: Clinical Research Monitor Team Lead
  • Direct Reports: No
  • Status: Exempt
  • Office location: Hoosier Cancer Research Network, 7676 Interactive Way, Suite 120, Indianapolis, Indiana. Hybrid 3/2 schedule during training then moving to a remote role with monthly in-person meetings.
  • Work week: 40+ hours/week
  • Travel: 80%