Research Assistant I Tri

AdventHealth•Orlando, FL

60d•Onsite

About The Position

The Clinical Research Assistant I (RA I) 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 RA I 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 subjects, investigators, CRC's and other staff. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

Requirements

High School Grad or Equiv Required
3 Work Experience Required
Ability to perform clinical tasks including assisting physician, ARNP, PA, CRC and CRN with minor procedures and other study requirements, as needed.

Responsibilities

Practices the principles of Universal Precautions and understands and abides by HIPAA regulations.
Conforms to all standards of good research practice and provides support to research patients by abiding by current IRB, FDA, federal, state, and institutional regulations pertaining to human subjects research.
Assists the research team by communicating patient events and concerns regarding the patients level of understanding.
Functions as a patient advocate by escalating patient concerns to the research team.
Assists the research team in maintaining neat, organized, accurate, and up-to-date source document records and databases for all participants.
Completes Case Report Forms (CRFs), subject tracking tools, registries & databases in a timely manner, ensuring that all data collection meets protocol specifications and requirements.
Has a basic understanding of protocol documents and performs required activities with the assistance of the research team.
Communicates with the research team regarding research project status, patient statuses (such as adverse events) and data inconsistencies.
Assists with source document completion for all required/reported data and submits data within the specified time frame.
Assists with the maintenance of study charts, registries, and other research documents to coincide with current patient status.
Maintains a clean, prepared clinical space and performs set-up and turnover procedures in all clinical areas per SOPs and/or Working Instructions in a timely manner.