Provide safe and efficient age-specific nursing care to patients/families using the nursing process in combination with clinical research protocol requirements. Works in collaboration with the Principal Investigator to coordinate and implement assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines

• Responsible for submission of related documents to the appropriate research review committees and maintenance of regulatory documentation.
• Performs day-to-day activities related to clinical research studies including: recruit and screens participants, obtain informed consent, educate participants regarding study requirements, and complete source documents and case report forms (CRFs).
• Conducts nursing assessments of research participants including appropriate reporting.
• 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 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.

Education

• (BSN) Bachelor's Degree in Nursing (Required)

Work Experience

• 2+ years of clinical experience in patient care (Required)
• Clinical research experience (Preferred)
• Experience in a team setting (Preferred)

Experience in diabetic research is preferred

Pharmaceutical clinical trials experience is preferred

Knowledge, Skills, & Abilities

• Ability to prioritize the work of multiple projects. (Required proficiency)
• Knowledge of GCP and FDA guidelines. (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. (Required proficiency)
• Able to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Medical terminology. (Required proficiency)
• Effective verbal, written and communication skills. (Required proficiency)
• Computer skills : Excel, Access and Word. (Required proficiency)

Licenses and Certifications

• Registered Nurse (RN), Ohio and/or Multi State Compact License (Required Upon Hire) and
• Certification in Human Subjects Protection (CITI) Good Clinical Practices, HIPAA, and CITI Training (Required within 30 Days) and
• Basic Life Support (BLS) (Required within 30 Days) and
• OH Driver's License (Valid) with car insurance coverage. (Required)
• DOT/IATA Training (Required within 30 Days)

Physical Demands

• 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

Travel Requirements

• 10%