Clinical Research Data Specialist II, Seidman Cancer Center (Hybrid)

University Hospitals • Cleveland, OH

18d • Hybrid

About The Position

Independently coordinate and facilitate the clinical trial data for participants enrolled in clinical research studies conducted by principal investigator(s) at University Hospitals. Prepare and design data management study documentation.(20%25) 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%25) Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies of data in accordance with study submission/completion guidelines for a variety of studies in different therapeutic areas and phases including IND or IDE held investigator initiated trials. (30%25) 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%25) Provides mentorship and training on the clinical trial and data management process to staff members. Acts as a department liaison on interdepartmental committees.(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.

Requirements

• Bachelor's Degree (Required) and years of experience or research or data management certification (ie. SCDM, SoCRA or ACRP) can offset degree (Required)
• 3+ years of clinical research experience (Required)
• Experience with computer operations and demonstrated computer skills in a variety of software environments (ie Excel, Access, Word, database applications). (Required)
• Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Ability to work consistently and effectively as part of a high performance work team. (Required proficiency)
• Demonstrate problem solving skills and effective negotiation skills. (Required proficiency)
• Ability to understand and communicate data requirements to others. (Required proficiency)
• Medical terminology. (Required proficiency)
• Excellent verbal, written, interpersonal and written communication skills. (Required proficiency)
• Certification in Human Subjects Protection (CITI) (Required within 30 Days)

Responsibilities

• Prepare and design data management study documentation.
• 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.
• Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies of data in accordance with study submission/completion guidelines for a variety of studies in different therapeutic areas and phases including IND or IDE held investigator initiated trials.
• 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.
• Provides mentorship and training on the clinical trial and data management process to staff members. Acts as a department liaison on interdepartmental committees.
• Performs other duties as assigned.
• Complies with all policies and standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees