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%)
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%)
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.
Qualifications
Education
Bachelor’s Degree (Required) or
Associate’s Degree with 4 years of healthcare or research-related experience (Required)
Work Experience
Experience in a team setting (Preferred)
Knowledge, Skills, & 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) within 30 Days (Required)
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% Travel may be required.
Seniority level
Entry level
Employment type
Full-time
Job function
Health Care Provider
Industries
Hospitals and Health Care
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