• Full Time
  • Chicago

Website Hektoen Institute LLC

OVERVIEW

Provides leadership, strategic management, and administration for the National Cancer Institute-funded community oncology clinical trials research program. Supervises and manages the research staff in the division. Serves as the key operational interface between the funding agencies, research bases, research team and principal investigators.  This position will be responsible for the management and oversight of pre-award and post-award activities relating to clinical research studies in collaboration with Hektoen Institute. This includes preparing research budgets, contract negotiations and post award management.  This position works with a multidisciplinary team of physicians and staff to maintain an environment that encourages collaboration and partnership in clinical trials research.

RESPONSIBILITIES

Research Administration

  • Assists clinical trials working group in identifying new clinical trials and studies funding opportunities, provides insight on funding terms and conditions and submission requirements, assists with preparing applications for funding.
  • Assists Principal Investigators (PIs) with day-to-day clinical trials management duties: budgeting, purchasing, and expense reconciliation; contract, reimbursement submissions; position requests and salary reallocations.
  • Works with the Hektoen Institute to facilitate contract negotiations and execution through the Cook County Health Office of Innovation.
  • Assists PI, Associate PI and Administrator with internal and external budget development for clinical trials research applications.
  • Monitors funds on regular basis, reconciling staff salaries, invoices, incoming research payments, cost transfers and other expenses ensuring financial compliance to reporting standards and funding agency requirements.
  • Provides regular financial status updates including fiscal projections to PIs and Administrator
  • Reviews and coordinates time and effort reporting for clinical research staff.
  • Responsible for annual progress reports, contract amendments and collaborates with Hektoen Institute in the completion of required federal financial reports, just in time submissions, and no-cost extensions.
  • Works with the clinical research team to ensure proper and timely data entry on all studies, offering training and guidance as appropriate.
  • Provides oversight of patient clinical trials milestone actions to ensure proper reimbursement from research groups; Reconciles patient actions with funds received.
  • Management, Coordination, and Communication:
  • Works with other departments/disciplines to coordinate all aspects of research studies.
  • Monitors, directs and performs day-to-day operations to ensure policies and procedures are being followed, objectives are being met and that services and projects are run efficiently and effectively.
  • Recruits and supervises research personnel, including training and mentoring research staff and providing opportunities for staff education, development, and professional growth. Plans, directs, schedules and manages resources and efforts of teams to support the operational needs and strategic objectives.
  • Collaborates with PIs and Administrator to establish strategic plans, policies, and procedures to assist the division and department in fulfilling its research goals and objectives.
  • Promotes the research activities within the division, participates in local and national meetings, and works with the faculty to report results via publications and presentations.
  • Oversees and provides guidance to research staff in study procedures and processes and monitors team workflow.

Regulatory Compliance:

  • Lead research team through external audit process.
  • Oversees the preparation and submission of regulatory documents to the National Cancer Institute Central IRB and the Cook County Health IRB.
  • Oversees the maintenance of investigator/sponsor files in accordance with NIH, FDA, and Good Clinical Practice (GCP) Guidelines.
  • The authority to hire, separate, promote, demote, write, and administer performance evaluations.
  • Other job functions as assigned.

QUALIFICATIONS

Bachelor’s degree from accredited university. Experience in clinical research financial management or research award administration.  Staff management experience. Ability to communicate effectively in a leadership role with clinical, business and administrative staff. Ability to work with a team. Strong customer service skills. Excellent organizational skills. Exceptional verbal and written communications skills. Certification as a Clinical Research Professional (SOCRA) or Clinical Research Coordinator (ACRP) is a plus but not required.

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