Site Research Assistant

High School Diploma and 1 years’ relevant work experience in clinical research
Working knowledge of clinical trials
Working knowledge of the principles of Good Clinical Practices (GCP)
In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules
Skill in carrying out required clinical procedures
Working knowledge of medical terminology
Ability to pay close attention to detail
Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians, and clients
Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies

EDC Entry and Query Resolution
Develop strong working relationships and maintain effective communication with study team members
Develop strong working relationships with the investigators and office staff to build a foundation of trust and respect between the clinic and the research office
Assist with the screening, recruiting, and enrollment of research subjects
Perform patient/research participant scheduling
Collect patient/research participant history
Coordinate follow-up care and laboratory procedures
Adhere to an IRB-approved protocol
Assist in the informed consent process of research subjects
Support the safety of research subjects
Coordinate protocol-related research procedures, study visits, and follow-up care
Comply with company and Sponsor policies, standard operating procedures (SOPs), and guidelines
Schedule subject visits and procedures