About The Position

Responsible for the implementation, management and oversight of clinical trial research studies including the education of research staff, healthcare team member, participants and their caregivers. Registers, compiles, submits and oversees clinical data, monitors study compliance and maintains a system for effective data flow for patients on clinical trials. Manages patient visits and implements protocol related procedures. Responsible for monitoring and communicating study participant progress and safety issues with the investigators, applicable regulatory agencies, health care team and study staff.

Requirements

  • Associates degree in Allied Health OR Bachelor's Degree in health sciences or business-related field of study.
  • Two (2) years of research experience in at least one of the following areas: pharmaceutical, academic, device, NIH, investigator-initiated studies or registry trials.
  • BLS is required within six (6) months of employment.
  • Collaborative Institutional Training Initiative (CITI) preferred.
  • If Allied Health Degree: State certification/license in field.
  • Research Coordinator IIs may be required to have a valid driver’s license, an acceptable motor vehicle record, and proof of auto insurance.

Responsibilities

  • Assists in determining patient eligibility for enrollment in research studies.
  • Identifies individual patient needs to facilitate participation including identifying and pre-screening potential participants.
  • Registers patients into research studies to meet protocol parameters.
  • Assists MD investigator in the informed consent process.
  • Provides coordination over assigned research staff.
  • Ensures assigned study staff practice within the parameters of their qualifications.
  • Collaborates with other health team members to formulate an interdisciplinary plan of care.
  • Instructs participating health care team members in clinical trials procedures.
  • Interacts with other members of health team to monitor protocol compliance.
  • Identifies specific learning needs and abilities of patients/families.
  • Provides patients/families with information regarding clinical trial participation.
  • Gathers and abstracts study data and documents in a factual, concise manner.
  • Achieves timely, thorough and accurate completion and evaluation of case report forms.
  • Prepares for and manages pre-site, study initiation, interim monitoring, and close-out visits.
  • Collaborates with Prisma Health Research services and sponsoring agencies.
  • Attends Investigator Meetings as appropriate.
  • Manages study related inventory including data collection tools and study supplies.
  • Assists department manager/supervisor to coordinate resources to appropriately conduct the trial.
  • Communicates study related issues with research management.
  • Assists investigator in the development of investigator-initiated research studies.
  • Maintains professional growth and development through seminars and workshops.
  • Performs other duties as assigned.
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