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Research Coordinator

The Clinical Research Coordinator has advanced knowledge and understanding of the planning, implementation and management of research operations. The Clinical Research Coordinator is responsible for planning and management of the approval, implementation and conduct of research protocols from planning through completion and reporting, assuring that the processes, integrity and quality of the research are assessed and maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Verdi Policy and Procedure and research protocols. This role serves as a resource for inquiries and maintains communication with the Investigators, participants, sponsors, IRBs, DSMBs and other research related entities. Functions as a departmental resource in research operations.

Position Details:

Reports to: Clinical Research Manager
Department: Research
Location: Horizon Oncology & Research Center | Lafayette, IN

Duties and Responsibilities

  • Leads site start up activities.
  • Develops study specific care plans.
  • Provides staff training on new study protocols.
  • Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial.
  • Maintains continuing communication with the study participants to ensure their understanding of the study protocol, procedures, and requirements.
  • Accurately records source documentation in site EMR and study EDC systems.
  • Monitors and documents toxicities to treatment.
  • Reports Serious Adverse Events to sponsor and IRB as appropriate.
  • As necessary, assists with collection, processing, and shipment of specimens.
  • Dispenses oral investigational medications per protocol and regulatory guidelines.
  • Coordinates required study supplies.
  • Resolves queries from study sponsors within required timelines.
  • Actively participates in study close out procedures.
  • Serves as primary contact for trial specific issues.
  • Ensures compliance with federal, state, and organizational guidelines with regard to clinical research protocols.
  • Promotes Good Clinical Practices (GCP) in the conduct of clinical trials by possessing an in-depth knowledge of Federal Regulations and Guidance documents for the conduct of clinical trials and human subject protection.

Knowledge, Skills, and Abilities

  • Critical thinking skills.
  • Ability to track and perform multiple tasks.
  • Ability to manage large volumes of information.
  • Excellent verbal and written communication skills.
  • Must possess a good working knowledge of basic clinical research practice.
  • Ability to utilize keen judgment in evaluating information.
  • Ability to numerically and accurately enter and calculate test results in an electronic database.
  • Ability to work in a stressful environment.
  • Must be team oriented.

Basic Qualifications

  • Current RN or LPN license in the state of Indiana.
  • Previous Experience in Clinical Research preferred.
  • Previous Oncology Experience preferred.

To apply, submit your resume to [email protected]