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

What You Will Do

• Assists with the submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%25)
• 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%25)
• Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (20%25)
• 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%25)
• Establish and maintain communications with Investigator, Sponsor and internal constituents. (10%25)
• Performs other related duties as assigned or required. (10%25)

Additional Responsibilities
 

• 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 Qualifications

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

Experience Qualifications

• Experience in a team setting (Preferred)

Skills and Abilities

• Ability to assist the work on multiple projects. (Required proficiency)
• Medical terminology or basic research terminology. (Preferred proficiency)
• DOT/IATA Training. (Preferred 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)

Licenses and Certifications

• Certification in Human Subjects Protection (CITI) (Required within 30 Days)

Physical Demands

• Standing - Frequently
• Walking - Frequently
• Sitting - Rarely
• Lifting - Frequently (up to 50 lbs)
• Carrying - Frequently (up to 50 lbs)
• Pushing - Frequently (up to 50 lbs)
• Pulling - Frequently (up to 50 lbs)
• Climbing - Occasionally (up to 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