Job Summary

Must have 3 consecutive years recent experience in a trial study

Responsibilities · Provide clinical research support to investigators to prepare for and execute assigned research studies, including:

· Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data;

· Attend all relevant study meetings;

· Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research;

· Recruit and screen patients for clinical trials and maintain subject screening logs;

· Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits;

· Design and maintain source documentation based on protocol requirements;

· Schedule and execute study visits and perform study procedures;

· Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness;

· Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics;

· Monitor subject safety and report adverse reactions to appropriate medical personnel;

· Correspond with research subjects and troubleshoot study-related questions or issues;

· Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards;

· Assist with study data quality checking and query resolution.

Qualifications

Must have 3 consecutive years recent experience in a trial study

Phlebotomy experience / certification preferred

Spanish Speaking / Bilingual preferred