Job Description
Inspire health. Serve with compassion. Be the difference.
Job Summary 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.
Essential Functions - All team members are expected to be knowledgeable and compliant with Prisma Health's values: Inspire health. Serve with compassion. Be the difference.
- Independently compiles the 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 research nurses in screening, consenting, and re-consenting research subjects.
- Performs other duties as assigned.
Supervisory/Management Responsibilities - This is a non-management job that will report to a supervisor, manager, director or executive.
Minimum Requirements - Education - Associate degree in Clinical, Healthcare or Scientific related field of study.
- Experience - Three (3) years of Allied health, medical or research related experience
In Lieu Of - Bachelor's degree in clinical, healthcare or scientific related field required and one (1) year of experience may be considered
Required Certifications, Registrations, Licenses - SoCRA or ACRP certification- Preferred
- Oncology medical research experience- Preferred
- Some medical office experience preferable in oncology- Preferred
Knowledge, Skills and Abilities - Knowledge of office equipment (fax/copier)
- Computer skills (word processing, spreadsheets, database)
- Data entry skills
- Medical terminology knowledge - Preferred
Work Shift Day (United States of America)
Location Cancer Centers - Faris Road
Facility 1008 Greenville Memorial Hospital
Department 10559220 OP Oncology Research-CIF
Share your talent with us! Our vision is simple: to transform healthcare for the benefits of the communities we serve. The transformation of healthcare requires talented individuals in every role here at Prisma Health.
Job Tags
Full time, Shift work,