Clinical Research Specialist I, Clinical Trials Unit - University Hospitals

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

• 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, obtains informed consent, educates participants regarding study requirements and completes 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 records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external 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.
• Complies with all policies and standards.
• For specific duties and responsibilities, refer to documentation provided by the department during orientation.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.

• Bachelor's Degree Required or
• Associate's Degree with 4 years of healthcare or research-related experience Required

• Experience in a team setting Preferred

• Ability to assist the work on multiple projects. Required
• Medical terminology or basic research terminology. Preferred
• DOT/IATA Training. Preferred
• Detail-oriented person 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

• Standing Frequently
• Walking Frequently
• Sitting Rarely
• Lifting Frequently 50 lbs
• Carrying Frequently 50 lbs
• Pushing Frequently 50 lbs
• Pulling Frequently 50 lbs
• Climbing Occasionally 50 lbs
• Balancing Occasionally
• Stooping Frequently
• Kneeling Frequently
• Crouching Frequently
• Crawling Occasionally
• Reaching Frequently
• Handling Frequently
• Grasping Frequently
• Feeling Constantly
• Talking Constantly
• Hearing Constantly
• Repetitive Motions Constantly
• Eye/Hand/Foot Coordination Constantly

Primary Location

Work Locations

Job

Organization

Schedule

Employee Status

Job Type

Job Level

Travel

Job Posting