Hoosier Cancer Research Network (HCRN) is currently seeking a full-time clinical research monitor. Bachelor’s degree in life sciences or a related field, minimum of two years’ experience in clinical research (oncology preferred), familiarity with GCP, HIPAA, medical terminology, electronic medical records, and research compliance required. 

Job Description

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 

• 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).
• 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.
• Prepare and submit comprehensive monitoring reports in HCRN’s Electronic Data Capture (EDC) system following each site visit.
• 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.
• 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.
• 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.

Job 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%

Submit resumes by email to HR@hoosiercancer.org with “Clinical Research Monitor” in the subject line. 

No calls or walk-ins, please.

HCRN grants equal opportunity to all qualified persons without regard to race, color, religion, gender, pregnancy, disability, age, national origin, military service obligations, veteran status, citizenship, sexual orientation, or any other category protected by law. HCRN provides equal opportunity in wages, promotions, benefits, and all other privileges, terms, and conditions of employment. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

About Hoosier Cancer Research Network:
Hoosier Cancer Research Network conducts innovative cancer clinical trials in collaboration with more than 100 academic and community clinical research sites across the United States. Our studies are designed by cancer researchers from our member institutions. The HCRN staff includes 55 team members who work together to support all aspects of the studies we manage, from the time we receive the initial concept from a researcher through the final publication of the study results. Currently, we are supporting more than 70 clinical trials across a wide range of cancer types. Over our 40-year history, more than 10,000 participants in have enrolled in our clinical trials, leading to important discoveries that help cancer patients live longer and better after their cancer diagnosis.