Hoosier Cancer Research Network (HCRN) is currently seeking a full-time protocol and correlative development manager. Oncology clinical trial knowledge and/or experience is required. Experience as a clinical study trial coordinator, CRO project manager, correlative management or oncology research nurse is preferred.

HCRN is an independent nonprofit contract research organization based in Indianapolis, Ind., that specializes in early phase, multi-center, investigator-initiated oncology clinical trials. Our studies are conducted through a nationwide network of more than 100 academic and community sites.

Job Description

• Review clinical trial proposals received from academic medical centers to identify specific patient care requirements and related trial activities.
• Support the Research Development Officer in preparing budgets for these clinical trials. Ensure budgeted costs are accurate, timely and properly categorized as trial-specific or standard of care.
• Work with clinical trial sponsors (academic medical centers) and funders (pharmaceutical companies and research foundations) to ensure that budgets reflect changes in trial design and care delivery.
• Track the status of all trial budgets as they move from proposal to execution. Maintain trial budgets in HCRN’s project management tools and update throughout the budgeting process.
• Collaborate with Finance to regularly adjust budget templates for new medical cost estimates.
• Research oncology treatment regimens to understand if specific trial activities reflect current standards of care.
• Communicate with the universities and hospitals sponsoring the clinical trials to understand their trial-specific activities, costs, and timelines so initial budget submissions are reflective of those costs.
• Assist in identifying appropriate laboratories for correlative testing. Seek laboratory quotes for analysis and sample processing and facilitate vendor assessment.
• Collaborate with protocol development team and investigators to prepare and review study protocols and consents involving translational studies and correlative sample collection.
• Create and maintain correlative specimen table for each study in accordance with the protocol and correlative study needs.
• Work with investigators to obtain correlative research quotes for needed kits, shipping, and analysis of the protocols correlative component.
• Other duties as assigned.

Qualifications:

• Oncology clinical trial knowledge and/or experience is required.
• Experience as a clinical study trail coordinator, CRO project manager, correlative management or oncology research nurse is preferred.
• Individuals with experience in clinical research billing compliance would also be considered for this role.

Language Skills:

• Ability to read and interpret documents such as computer software and documentation and procedure manuals. Will have the ability to draft 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 the 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.

Submit resumes and references by email to LeaEtta Hyer at lhyer@hoosiercancer.org with “Protocol and Correlative Development Manager” in the subject line.