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Responsible for the accurate and timely completion of clinical research subject Case Report Forms. The Research Data Specialist (RDS) supports the clinical research team of the Northside Hospital Research Program. Responsibilities involve patient registration, data management, adverse event reporting, maintenance of a Clinical Trials Management System, and other activities related to research. The RDS works closely with the Clinical Research Nurses (CRN) and Clinical Research Coordinators (CRC) to complete all data-related tasks. The RDS serves as a resource for the clinical research team regarding all aspects of data management to achieve optimal research outcomes and quality.

PRIMARY DUTIES AND RESPONSIBILITIES

• Independently completes CRFs (paper and electronic) in a timely and accurate fashion in accordance with protocol, regulations, and CRF guidelines.
• Obtains, and maintains, database access/training, timely. Responds to data queries in a complete, accurate and timely manner.
• Reviews and completes on-site queries and corrections as required during monitor/audit visits in collaboration with research team.
• Maintains study supplies (lab kits, radiology/imaging supplies, CRFs, etc.) in accordance with protocol requirements. Packaging and shipping of biologic samples in compliance with protocol and federal guidelines. May attend research procedures to ensure protocol specific collection of samples (may require travel to various clinics and associated locations).
• Assists CRNs and CRCs in retrieving radiology films, lab specimens, hospital records. This may require travel to various clinics and associated hospitals.
• Assists department in preparing for audits and monitor visits.
• Organizes and maintains study related medical information in the research source document (medical chart).
• Maintains subject pre-screen, screening, and on-study information on a concurrent basis using Clinical Trials Management System and other tools as appropriate.
• Assists CRN/CRC to manage clinic site study visit calendars while coordinating investigator availability and the availability of any ancillary services required by the study protocol.
• Maintains subject follow-up schedules and information as required by the protocol.

This Research Data Specialist would cover our Forsyth Hub.

Hubs: Atlanta Cancer Care Cumming, Georgia Cancer Specialist Cumming, University Gynecologic Oncology (UGO) Forsyth, Melanoma & Sarcoma Specialists of Georgia (MSSOG) Forsyth, & Radiation Oncology Cumming

REQUIRED:

• Associates Degree from an accredited college or university OR Graduate of an Allied Health Program (Medical Assistant, Certified Nurse Aide, Lab Tech, Infusion Tech, etc)
• If not Certified Clinical Research Professional (CCRP) at time of hire, must achieve professional certification through Society of Clinical Research Associates (SOCRA) by deadline assigned to specific work location.
• Knowledge and understanding of the clinical environment.
• Proficient in computer systems with expertise in use of Microsoft Office Suite.

Preferred:

Oncology patient experience preferred.

Oncology medical terminology preferred.