Clinical Research Specialist I, OB/GYN

Position Overview

Under the direct supervision of the Principal Investigator and senior study staff, assists with the coordination and implementation of assigned clinical research trials.

Key Responsibilities

• Assists with the submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%)
• Performs assigned activities related to clinical research studies including but not limited to: screening participants for eligibility and recruitment, obtaining informed consent, educating participants regarding study requirements, and completing source documents and case reporting forms. (30%)
• Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (20%)
• Documents, records and assimilates accurate participant and study records to ensure compliance with sponsor guidelines, standard operating procedures (SOP) and regulatory agencies. (20%)
• Establish and maintain communications with Investigator, Sponsor and internal constituents. (10%)
• Performs other related duties as assigned or required. (10%)
• Performs other duties as assigned and complies with all policies and standards.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI). Annual training, the UH Code of Conduct and policies/procedures ensure the appropriate use of PHI in the workplace.

Required Qualifications

• Bachelor's Degree (Required) or Associate's Degree with 4 years of healthcare or research-related experience.
• Ability to assist on multiple projects. (Required)
• Detail-oriented with the ability to collect, compile, and analyze information. (Required)
• Able to work independently on multiple tasks and manage time effectively. (Required)
• Excellent verbal, written, interpersonal and communication skills. (Required)
• Computer skills: Excel, PowerPoint, and Word. (Required)
• Certification in Human Subjects Protection (CITI) (Required within 30 Days)

Preferred Qualifications

• Experience in a team setting.
• Familiarity with medical or basic research terminology. (Preferred)
• DOT/IATA Training. (Preferred)