JOB DESCRIPTIONJOB SUMMARYParticipates in large scale and/or multiple protocol clinical research studies conducted by the principal investigator(s) at Wake Forest University School of Medicine. Coordinates and participates in a variety of activities involved in the collection, compilation, documentation of clinical research data.
EDUCATION/EXPERIENCEBachelor's degree in Education, Public Health, Basic Science or a relevant clinical discipline with three years of survey research experience including interviewing and supervision of data collection; or, an equivalent combination of education and experience.
LICENSURE, CERTIFICATION, and/or REGISTRATIONSociety of Clinical Research Associates (SoCRA) or Association of Clinical Research Professional (ACRP) certification required.
ESSENTIAL FUNCTIONS- Participates in clinical research studies conducted by the principal investigator(s) at Wake Forest University School of Medicine. Performs variety of activities involved in the collection, compilation, documentation and analysis of clinical research data.
- Follows established guidelines in collection of clinical data and/or administration of clinical studies.
- Participates in procedures to collect patient data for use in clinical research studies including consenting, implementing procedures and/or treatment plans to alleviate patients concerns under the direction of the RAII. Schedules patients for study procedures; initiate/coordinate drug orders, laboratory procedures and treatments for patient based on standing protocol orders. Collects data from patients charts, medical records, interviews, questionnaires, diagnostic test and other sources; evaluate and interpret collected data and prepare appropriate documentation; obtain samples specific to therapeutic area for laboratory analysis and review.
- Ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitor patient's progress to include documentation and reporting of adverse events; recommend corrective actions as appropriate.
- Assists with development of collection methods. Creates and revises study materials, forms, manuals and brochures as requested.
- Evaluates and interprets collected clinical data in conjunction with principal investigator(s) as appropriate.
- Orders and maintains adequate supplies for the project.
- Establishes and maintains separate billing files on specific accounts related to individual departments/sections during the course of the project.
- Provides guidance to lower level personnel involved in implementation clinical studies.
- Reviews journals, abstracts and scientific literature to keep abreast of new developments in assigned therapeutic area.
- Performs other duties as assigned by management.
SKILLS/QUALIFICATIONS- Knowledge of computerized data processing
- Proficiency in Microsoft Office applications
- Ability to prioritize and organize a high volume workload and changing priorities
- Familiar with principles of protocol development, study design, statistics, and IRB process
- Ability to direct the work of others
- Ability to maintain patient confidentiality and comply with HIPAA regulations
WORK ENVIRONMENT- An indoor, clinical research setting
- Exposure to human bodily fluids
- Laboratory processing procedures
- Subject/patient care
About UsWake Forest University School of Medicine (WFUSM) is a U.S. News and World Report top 50 ranked medical school, integrated with a world-class health system, Atrium Health. WFUSM, the academic core of Atrium Health Enterprise, is a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery. WFUSM, has over $300M in annual, extramural funding that drives a cutting-edge Academic Learning Health System by integrating innovative research with excellent patient care across our enterprise.
Atrium Health Wake Forest Baptist is based in Winston-Salem, North Carolina and is part of Advocate Health, which is headquartered in Charlotte, North Carolina, and is the fifth-largest nonprofit health system in the United States, created from the combination of Atrium Health and Advocate Aurora Health. AHWFB is an 885-bed tertiary-care hospital in Winston-Salem - that includes Brenner Children's Hospital, five community hospitals, more than 300 primary and specialty care locations and more than 2,700 physicians. Our highly integrated academic and clinical environment is deeply committed to improving health, elevating hope, and advancing healing - for all.
It should be noted that while you are applying on the Wake Forest University School of Medicine Career Site, you will receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process. Thanks in advance for your flexibility.
About the TeamMission, Vision and Culture CommitmentsMissionTo improve health, elevate hope and advance healing - for all.
VisionTo be the first and best choice for care.
Culture CommitmentsWe create a space where all Belong
We Work as One to make great things happen
We earn Trust in all we do
We Innovate to better the now and create the future
We drive for Excellence - always