Research Compliance Analyst I

2 weeks ago


Chardon, Ohio, United States University Hospitals Full time
Position Overview
As a vital member of the research compliance team, you will play a crucial role in ensuring adherence to regulatory standards and institutional policies regarding research activities. Your responsibilities will include:
  • Compliance Reviews: Conducting both directed and prospective evaluations of research activities across the organization, generating focused and timely reports, and ensuring thorough completion of all reviews. (60%)
  • Regulatory Knowledge: Keeping abreast of federal regulations, ethical considerations, and institutional research policies related to the protection of human research participants, while identifying areas for quality enhancement. (15%)
  • Support and Investigation: Assisting the research community in maintaining compliance with applicable federal and institutional policies; providing support during investigations of non-compliance allegations. (25%)
Additional Duties
  • Performing other assigned responsibilities.
  • Adhering to all relevant policies and standards.
  • Referencing specific duties and responsibilities as outlined in departmental documentation during orientation.
  • Ensuring the safe and secure handling of Protected Health Information (PHI) for patients, in accordance with annual training and established policies.
Qualifications
Education
  • Bachelor's Degree (Required)
Experience
  • Minimum of 1 year in health-related research (Required)
  • Experience in research monitoring or auditing (Preferred)
Knowledge, Skills, & Abilities
  • Strong clinical background with a solid understanding of medical treatments, procedures, and medications (Required proficiency)
  • Comprehensive knowledge of responsible research conduct and misconduct regulations (Required proficiency)
  • Exceptional interpersonal skills and professional demeanor (Required proficiency)
  • Strong organizational and writing capabilities (Required proficiency)
  • Proficiency in computer applications, including Microsoft Office (Required proficiency)
Licenses and Certifications
  • Certification in Human Subjects Protection (CITI) within 30 days (Required)
  • Certification as a Clinical Research Coordinator (CCRC) or other relevant research certifications (Preferred)
Physical Requirements
  • Occasional standing and walking
  • Constant sitting
  • Rare lifting and carrying of up to 20 lbs
  • Frequent talking and hearing
  • Regular repetitive motions and coordination
Travel Requirements
  • Up to 10% travel may be required.

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