Clinical Research Data Specialist I, Clinical Trials (Hybrid)

What You Will Do

• Coordinate and facilitate the clinical trial data for participants enrolled in clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center. (20%)
• Assist and complete case report forms entry, review and abstraction required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees. (30%)
• Provide timely and professional ongoing data entry of clinical trial data by identifying errors and inconsistencies of data in accordance with study submission/completion guidelines across a variety of studies indifferent therapeutic areas and phases. (30%)
• Assure that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with SOPs, GCP guidelines, sponsor guidelines and current regulations. (20%)

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

• High School Equivalent / GED (Required)

Knowledge, Skills, & Abilities

• Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Ability to understand and communicate data requirements to others. (Required proficiency)
• Medical terminology (Preferred proficiency)
• Excellent verbal, written, interpersonal and written communication skills. (Required proficiency)
• Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments (ie Excel, Access, Word, database applications). (Required proficiency)

Physical Demands

• Standing Occasionally
• Walking Occasionally
• Sitting Constantly
• Lifting Rarely up to 20 lbs
• Carrying Rarely up to 20 lbs
• Pushing Rarely up to 20 lbs
• Pulling Rarely up to 20 lbs
• Climbing Rarely up to 20 lbs
• Balancing Rarely
• Stooping Rarely
• Kneeling Rarely
• Crouching Rarely
• Crawling Rarely
• Reaching Rarely
• Handling Occasionally
• Grasping Occasionally
• Feeling Rarely
• Talking Constantly
• Hearing Constantly
• Repetitive Motions Frequently
• Eye/Hand/Foot Coordination Frequently

Travel Requirements

• 10%