Research Compliance Analyst I
2 weeks ago
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%)
- 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.
Education
- Bachelor's Degree (Required)
- Minimum of 1 year in health-related research (Required)
- Experience in research monitoring or auditing (Preferred)
- 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)
- Certification in Human Subjects Protection (CITI) within 30 days (Required)
- Certification as a Clinical Research Coordinator (CCRC) or other relevant research certifications (Preferred)
- Occasional standing and walking
- Constant sitting
- Rare lifting and carrying of up to 20 lbs
- Frequent talking and hearing
- Regular repetitive motions and coordination
- Up to 10% travel may be required.
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