About The Position

Assists with screening, consents, enrollment and maintaining research subjects as well as maintain compliance to research protocols. Acts as the liaison between monitors, investigators and study personnel regarding all data management for patients enrolled in clinical trials. Responsible for abstraction of accurate, complete and timely data from the medical record, as needed. Maintains protocol regulatory documents in compliance with standard operating procedures (SOPs). Provides a safe environment for patients, families and clinical staff. All team members are expected to be knowledgeable and compliant with Prisma Health's purpose: Inspire health. Serve with compassion. Be the difference. Prisma Health is the largest not-for-profit health organization in South Carolina, serving more than 1.2 million patients annually. Our 32,000 team members are dedicated to supporting the health and well-being of you and your family. Our promise is to: Inspire health. Serve with compassion. Be the difference.

Requirements

  • Associate degree in Clinical, Healthcare or Scientific related field of study.
  • Two (2) years of Allied health, medical or research related experience.
  • Equivalent combination of work/academic experience may be considered (i.e., Bachelor's degree in clinical, healthcare or scientific related field of study) in lieu of education and experience noted above.
  • Computer skills (word processing, spreadsheets, database, data entry).

Nice To Haves

  • SoCRA or ACRP certification
  • Oncology medical research experience
  • Some medical office experience preferable in oncology
  • Medical terminology knowledge

Responsibilities

  • Compiles medical records of research subjects during the on-study, treatment and follow-up periods and reports required elements to the research sponsor in a complete, accurate and timely manner.
  • Ensures protocol compliance and accurate data submissions during the treatment and post treatment phase of a research trial.
  • Ensures that research tasks are completed correctly by referencing the most current copy of the research protocol and by accessing the research sponsor resources to complete tasks.
  • Ensures compliance with regulatory requirements throughout the study process.
  • Maintains accurate data on research patients in the research department database.
  • Ensures medical record accurately reflects research billing guides.
  • Develops and maintains a systematic approach to ensure all research data is reported in the time frame specified by the protocol.
  • Performs query resolution in a timely manner.
  • Prepares research records and participates in monitor visits or audit inspections.
  • Participates in protocol specific training (initiation visits) conducted by the sponsor.
  • Facilitates communication between the study sponsor, research nurses and investigators.
  • Performs tasks associated with enrollment and active treatment period of research subjects.
  • Collects and ships research specimens, gathers and submits radiological scans, performs clinical procedures such as EKGs as required by the research sponsor.
  • Assists in ensuring investigational drugs are maintained and distributed according to the protocol and FDA guidelines.
  • Assists in screening, consenting, and re-consenting research subjects.
  • Performs other duties as assigned.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Education Level

Associate degree

Number of Employees

5,001-10,000 employees

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