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Clinical Research Compliance Manager
2 months ago
For those currently employed at the University of Miami, please utilize the internal application process via Workday. Refer to the provided tip sheet for guidance on applying for faculty or staff positions.
The University of Miami is actively seeking a Clinical Research Compliance Manager to oversee operations at Desai Sethi Medical Center in Miami. This role is pivotal in establishing, managing, and achieving the milestones of clinical studies while adhering to relevant clinical and regulatory standards concerning human subject protocols. The position also involves training and mentoring all RSQA clinical research monitors, alongside providing oversight for CRO vendors.
CORE JOB FUNCTIONS
1. Supervises clinical research monitors to ensure effective investigational site monitoring and study activities.
2. Proactively identifies study-related issues and implements appropriate solutions, engaging necessary decision-makers.
3. Anticipates data requirements and develops tools for efficient study management, assisting in database design and data reporting.
4. Facilitates the creation of site training documentation and materials, contributing to the development and maintenance of policy and procedure manuals.
5. Aids in the formulation and documentation of clinical protocols, case report forms, and other essential study documents, conducting co-monitoring visits with RSQA clinical research monitors.
6. Assesses the quality and completeness of data and participant safety documentation, ensuring compliance with research regulations and protocols. Monitors legislative changes that may impact the University's research compliance and recommends necessary adjustments to administrative policies.
7. Produces monitoring reports and follow-up correspondence regarding findings, tracking resolutions. Maintains records of monitoring activities and prepares necessary reports and responses.
8. Provides expert consultation on quality control and regulatory matters to research sites and investigators through on-site visits. Advises institutional officials on deficiencies and recommends corrective actions, ensuring follow-up on implementation.
9. Prepares for internal and external audits, ensuring compliance with federal, state, and local regulations, as well as extramural agency requirements.
10. Assists in developing and presenting educational programs for the University research community, offering regulatory support to principal investigators and research teams.
11. Aids in establishing and maintaining a CAPA (Corrective Action Preventive Action) system.
12. Maintains RSQA-related databases and audit files, both electronic and paper. Assists in preparing annual RSQA reports summarizing efforts and proposed changes at the University and departmental levels.
13. Continuously evaluates the effectiveness of internal controls within the unit and compliance with University policies, ensuring staff are trained on relevant controls and procedures.
Department Specific Functions
1. Supports investigators and research teams with the study initiation process, including submissions to relevant committees.
2. Oversees the maintenance of studies post-activation, including amendments, modifications, and closures.
3. Conducts internal monitoring after approval, including routine quality assessments, and assists with audits and query resolutions.
4. Ensures research credentials for investigators and team members are current, including certifications and training.
5. Aids investigators with reportable new information, including deviations and developing CAPA plans, while enforcing compliance with regulatory policies.
This list of responsibilities is not exhaustive and may be expanded to include additional duties as necessary.
CORE QUALIFICATIONS
Education:
Bachelor's degree in a relevant field is required.
Master's degree is preferred.
Experience:
A minimum of 5 years of relevant experience is required.
The University of Miami offers competitive salaries and a comprehensive benefits package, including medical, dental, and tuition remission.
UHealth-University of Miami Health System is dedicated to providing exceptional patient care, driven by innovative research and medical education. Our academic medical center serves a diverse population, offering a wide range of specialties and sub-specialties.
Ensuring patient safety is paramount. During the flu season, all employees involved in patient care are required to receive an annual influenza vaccination, with non-compliance resulting in employment consequences.
The University of Miami is an Equal Opportunity Employer, encouraging applications from diverse backgrounds, including females, minorities, protected veterans, and individuals with disabilities.
Job Status: Full time Employee Type: Staff Pay Grade: H13