JOB SUMMARY

The Research Assistant (RA) is responsible for assisting with document management, protocol-related clinical assessments of research subjects, laboratory functions, and assisting in tasks related to the work of the Clinical Research Coordinators.

RESPONSIBILITIES

• Entering subject information into one or more databases
• Maintenance of database information
• Assisting in subject visits, including direct contact with subjects, processing of visit data, ensuring the completeness and integrity of source documents and case report forms (CRFs), and other related duties.
• Preparation for office/laboratory visits (i.e., “set-up”)
• Reading and understanding study protocols
• Participation in a clinical preceptorship whereby training in clinical skills will be provided by a research clinician or experienced technician. Clinical skills that will be expected after training include phlebotomy, vital sign measurement, performing ECGs, and assessment of general health.
• Performing clinical assessments of study subjects as per protocol, as delegated by PI, and under the direct supervision of a licensed clinician. These assessments include, but are not limited to, collecting VS, performing ECG and venipuncture, etc.
• All work is done following Good Clinical Practices (GCPs), Corporate Standard Operating Procedures (SOPs), and principles outlined in the CFR 21 and ICH guidelines.
• Other duties as assigned

 It is an onsite position and requires a flexible schedule. 

• The position requires at least a high school diploma or equivalent, but individuals with college degrees or experience in healthcare and/or relevant research are preferred.  
• The RA must possess excellent clerical skills, and good interpersonal skills, and must be able to provide accurate documentation of his or her work.  
• The research assistant must be willing to learn and be able to develop proficiency in clinical skills including phlebotomy, vital sign measurements, and performing ECGs under the preceptorship of a clinician or experienced research technician. Previous experience or knowledge of such clinical skills is preferred.