Understands the main objectives of each ongoing study and the study procedures for which he/she will be responsible.
Demonstrates proficiency at performing basic clinical procedures such as vital signs, ECGs, phlebotomy (not required), 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 onsite.
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.
Assists in the transcription of study data from source documents to Case Report Forms (CRFs)/ (eCRFs).
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 Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Participates as requested in Continuous Quality Improvement (CQI) process.
Flexibility to work mornings, evenings, and/or overnight shifts as needed.
Attends and participates in all required training activities.
Participates as requested as a Clinical Operations Study Liaison.
Assists with Screening Receptionist duties and responsibilities as requested.
Assists with Recruitment duties and responsibilities as requested.
Required Skills:
Demonstrates proficiency at performing basic clinical procedures such as vital signs, ECGs, and sample processing.