Clinical Research Specialist I, Clinical Trials Unit

University Hospitals • Cleveland, OH

12h • Onsite

About The Position

Under the direct supervision of the Principal Investigator and senior study staff, assists with the coordination and implementation of assigned clinical research trials. This role involves assisting with regulatory submissions, participant screening and recruitment, obtaining informed consent, educating participants, and completing source documents and case reporting forms. The specialist will maintain in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines, ensuring accurate documentation and compliance with sponsor guidelines, SOPs, and regulatory agencies. Communication with the Investigator, Sponsor, and internal constituents is also a key responsibility. The role also includes performing other related duties as assigned, complying with all policies and standards, and abiding by requirements for the safe and secure maintenance of Protected Health Information (PHI).

Requirements

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

Nice To Haves

• Experience in a team setting (Preferred)
• Medical terminology or basic research terminology. (Preferred proficiency)
• DOT/IATA Training. (Preferred proficiency)

Responsibilities

• Assists with the submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files.
• Performs assigned activities related to clinical research studies including but not limited to: Screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes source documents and case reporting forms.
• Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines.
• Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies.
• Establish and maintain communications with Investigator, Sponsor and internal constituents.
• Performs other related duties as assigned or required.
• Performs other duties as assigned.
• Complies with all policies and standards.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree