Clinical Research Data Specialist II - Integrative Medicine

Cleveland, Ohio

Employer: University Hospitals
Industry: Research
Salary: Competitive
Job type: Full-Time
What You Will Do
  • 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.
  • 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.


Connor Integrative Medicine Responsibilities:
  • Electronic health record (EHR) data mining for all Connor Whole Health (CWH) modalities
  • Preparing reports on all CWH modalities
  • Monitoring patient-reported outcome measure completion rates among clinics and providers
  • Data preparation/cleaning for practice-based observational studies
  • Coordinating data management between various stakeholders (e.g., Fertility clinic, CAISIS cancer registry, peds infectious disease)
  • Literature review as needed for various projects
  • REDCap building and management for observational studies and clinical trials


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)
  • Years of experience or research or data management certification (ie. SCDM, SoCRA or ACRP) can offset degree (Required)

Work Experience
  • 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)

Knowledge, Skills, & Abilities
  • 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)
  • Intermediate-advanced R skills
  • Intermediate-advanced s tructure query language (SQL) skills
  • Organized
  • Assertive
  • Intermediate-advanced Microsoft Office skills

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


Preferred Qualifications

Core skills that are needed include intermediate-to-advanced knowledge in 3 programming languages/data platforms: R, SQL, and REDCap. The ideal candidate will have skills applying SQL to Epic (e.g., Caboodle and Clarity databases).

Physical Demands
  • Standing Occasionally
  • Walking Occasionally
  • Sitting Constantly
  • Lifting Rarely 20 lbs
  • Carrying Rarely 20 lbs
  • Pushing Rarely 20 lbs
  • Pulling Rarely 20 lbs
  • Climbing Rarely 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
  • 25%
Created: 2024-10-07
Reference: 24000A6V
Country: United States
State: Ohio
City: Cleveland
ZIP: 44135

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