Executive Director leading firm - wide Compliance Risk Assessment program for SMBC Group in financial services. Managing CRA process and collaborating with regulatory stakeholders.
About the role
- Regulatory Affairs Coordinator supporting clinical trials and studies in the Hematology Division. Collaborating with investigators and regulatory bodies for efficient research processes.
Responsibilities
- Serves as regulatory contact person for ongoing clinical research studies.
- Meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.
- Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado.
- Writes clear and accurate subject informed consent documents and HIPAA Authorizations.
- Completes and submits continuing reviews, amendments, and safety updates as needed.
- Participates in Data Safety Monitoring Committee (DSMC) internal audits.
- Updates database with regulatory submission and approval dates.
Requirements
- Minimum Qualifications: Entry Level: Bachelor’s degree in any field.
- A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.
- Intermediate Level: Bachelor’s degree in any field.
- One (1) year clinical regulatory compliance or related experience.
- Senior Level: Bachelor’s degree in any field.
- Two (2) years clinical regulatory compliance or related experience.
- Preferred Qualifications: Bachelor’s degree in science or health related field.
- One (1) to three (3) years of clinical research or related experience.
- Knowledge, Skills, and Abilities: Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
- Ability to communicate effectively, both in writing and orally.
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
- Outstanding customer service skills.
- Knowledge of basic human anatomy, physiology, and medical terminology.
- Ability to interpret and master complex research protocol information.
Benefits
- Medical: Multiple plan options
- Dental: Multiple plan options
- Additional Insurance: Disability, Life, Vision
- Retirement 401(a) Plan: Employer contributes 10% of your gross pay
- Paid Time Off: Accruals over the year
- Vacation Days: 22/year (maximum accrual 352 hours)
- Sick Days: 15/year (unlimited maximum accrual)
- Holiday Days: 10/year
- Tuition Benefit: Employees have access to this benefit on all CU campuses
- ECO Pass: Reduced rate RTD Bus and light rail service
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