The Research Assistant position performs and manages all study-related clinical procedures according to the study protocol and provides nursing care under appropriate supervision for subjects enrolled in clinical trials. Perform duties in accordance with Profil’s values, policies, and procedures.
- Understands the main objectives and procedures of studies which s/he is assigned.
- Demonstrates proficiency at performing basic clinical procedures such as vital signs, ECGs, phlebotomy, and sample processing
- Demonstrates proficiency in documenting observations and study procedures correctly and legibly in the source document
- Understands and demonstrates proficiency in appropriately responding to medical emergencies on-site
- Performs study procedures as assigned
- Observes and records data related to patient safety and study procedures
- Ensures that all study data is recorded accurately and completely
- Assists nursing staff and Clinical Project Managers with study procedures and patient management as directed.
- Assist in the transcription of study data from source documents to Case Report Forms
- Understands and complies with Good Clinical Practices (GCPs), particularly those regarding the protection of human subjects and integrity of clinical trial data.
- Understands and complies with Profil Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- Participate as requested in Profil Continuous Quality Improvement (CQI) process
- Moderate flexibility to work mornings, evenings, and/or overnight and weekend shifts as needed
- Attend and participate in all required training activities
High school diploma or general education degree (GED) as well as experience as a Medical Assistant, EMT, LVN/RN, Phlebotomist, MD, or Corpsman in a clinical or laboratory setting and/or equivalent combination of medical education, training, certifications, and/or experience.
Able to perform basic clinical procedures correctly including vital signs, ECGs, phlebotomy, and sample processing. Demonstrates initiative and problem solving skills.
Able to respect and maintain subject confidentiality and blinding procedures.
Understands medical terminology and calculations.
Demonstrates a strong attention to detail with superior organizational skills.
Under general supervision, exercises judgment in accordance with well-defined policies, procedures, and techniques.
Able to self-monitor progress and complete assigned tasks independently.
Demonstrates strong interpersonal skills and the ability to work and communicate as an effective team member and with cross-functional groups. Basic Life Support (BLS) certification is required, and may be provided by the company.
Knowledge and/or Experience with Microsoft Excel
Profil Institute for Clinical Research, Inc. - 17 months ago