AdventHealth Celebration Health was designed as a Mediterranean resort-style facility to serve as a cornerstone of health in Disney’s planned community of Celebration, Florida
The hospital consistently delivers a state-of-the-art healing environment to residents of Osceola, Orange, Polk and Lake Counties, as well as to visitors from across the United States and the world. All within a 'living laboratory' of groundbreaking, research-driven clinical solutions that integrate mind, body and spirit in the defeat of illness and disease
Work Hours/Shift: Monday – Friday 9am – 5:30pm
The Research Support Assistant will assist the Clinical Research Coordinators (CRC)/Research Nurse in the conduct of Phase I-IV industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, FDA Regulations, and ICH/GCP Guidelines. The Research Support Assistant is immediately accountable to the CRC/CRN and works with them and other study team members to meet study-specific goals and timelines and communicates appropriately and effectively with other members of the study team (both internal staff and external collaborators). Assists with the recruiting needs of specific protocols and works with the team to meet these goals. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.
PRINCIPAL DUTIES AND JOB RESPONSIBILITIES:
· The Research Support Assistant is responsible for accurate and timely submission or filing of data forms, angiography, echocardiology, radiology and/or laboratory materials. Abstracts and records essential physical and test data. Submits data in time frame specified. Maintains study chart to coincide with current protocol and research participant visits. Responds to data clarification requests (queries) in a timely manner.
· Supports the CRC/CRN by assisting with: subject recruitment (assisting with subject prescreening); ensuring maintenance of proper research certifications; project timelines updates; and literary searches. Enters and updates information in to the data base for recruiting. Assists with study close out activities.
· Supports the research team by: creating/maintaining accurate files; copying, scanning, uploading, faxing and emailing documents as necessary; and being proactive in process improvement ideas.
· Communicates appropriately and effectively with investigators, scientists, APRN’s, CRN’s, industry collaborators, study monitors, physician offices, ancillary departments, staff and patients.
· Conforms to all standards of good research practice and abides by current IRB, FDA, federal, state and institutional regulations pertaining to human subjects research, including the use of institutional and departmental SOP’s. Understands and abides by HIPAA regulations.
· Understands the protocol document and performs required activities as exhibited through collaboration with the CRC/CRN. Participates in initial and ongoing protocol training as necessary for the study requirements. Communicates with the CRC/CRN incoming data and any inconsistencies.
· The Research Associate is responsible for maintaining personal professional growth and contributes to the growth of team members. Maintains adequate skills in technology as necessary for the study execution. Willingly participates in the orientation of new employees. Proactive in process improvement ideas. The CRA will contribute to providing the highest levels of customer service by maintaining open communication with other research staff and participating in inter and/or intradepartmental discussions relevant to research.
· Performs other duties as assigned or directed to ensure the smooth operation of the department or section.
KNOWLEDGE AND SKILLS REQUIRED:
· Strong interpersonal skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public.
· Excellent organizational, multi-tasking, and problem-solving skills with extreme attention to detail.
· Ability to work independently at a steady pace, performing multiple tasks and accommodate changing priorities.
· Proficient in Microsoft Office applications of Word, Outlook and Internet Skills
KNOWLEDGE AND SKILLS PREFERRED:
· Medical terminology exposure.
· Clinical Trials Management System (or equivalent) and/or Electronic Data Capture (EDC) exposure. Additional computer skills, particularly Excel, Publisher and data transfer portals.
· Knowledge of clinical research and research regulatory environment
EDUCATION AND EXPERIENCE REQUIRED:
· Associate degree in health science, or related field, OR
· 3 years equivalent administrative/professional experience, OR
· 2 years clinical research experience
EDUCATION AND EXPERIENCE PREFERRED:
· Bachelor’s degree in healthcare related field, data processing or business or related field.
· Medical Assistant or 1-2 years in a medical office (or equivalent)
· Previous research experience or administrative experience
LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:
LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:
AdventHealth Greater Orlando (formerly Florida Hospital) is one of the largest faith-based health care providers in the United States. For 150 years, we have carried on a tradition of providing whole-person care that not only addresses patients' physical ailments, but also supports their emotional and spiritual well-being. We demonstrate the same level of compassion and care for our employees as well, doing all that we can to help them realize their full potential – both personally and professionally.