Clinical Research Specialist II, Peds Hematology/Oncology (Hybrid)

University Hospitals • Cleveland, OH

1d • Hybrid

About The Position

Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials.

Requirements

• Bachelor's Degree (Required)
• 2+ years clinical research experience (Required)
• Experience in a team setting (Required)
• Ability to prioritize the work of multiple projects. (Required proficiency)
• Knowledge of GCP and FDA guidelines. (Required proficiency)
• Knowledge of Electronic Data Capture Programs. (Required proficiency)
• Medical & Research Terminology. (Required proficiency)
• Ability to train and mentor junior staff. (Required proficiency)
• Detail-oriented person with the ability to collect, compile, and analyze information. (Required proficiency)
• Ability to understand and communicate research protocol requirements to others. Able to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Demonstrates customer service excellence with internal and external customers (Required proficiency)
• Excellent verbal, written, interpersonal and communication skills. (Required proficiency)
• Computer skills (Outlook, Excel, PowerPoint, Word). (Required proficiency)
• Certification in Human Subjects Protection (CITI) (Required within 30 Days)

Nice To Haves

• DOT/IATA Training (Preferred proficiency)
• Society of Clinical Research Associates (SoCRA) (Preferred)
• ACRP Certified Professional (ACRP-CP) (Preferred)

Responsibilities

• Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files.
• Performs all 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 case report forms (CRF).
• 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.
• Assists with SOP, grant and protocol development and active participant in preparation of manuscripts and presentations for scientific meetings.
• Establish and maintain communications with Investigator, Sponsor and internal constituents.
• Mentorship of the clinical research process to the junior clinical research staff.
• Performs other related duties as assigned or required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level