Essential Functions:
Please include a cover letter with your application detailing your interest and qualifications for this position.
- Collaborates with key research leadership, employees, physicians, members of the Institutional Review Board (IRB) and research study sponsors to identify, research, investigate and resolve research-related compliance issues by serving as an internal expert and advisor in clinical research compliance matters
- Leads day to day operations of the Research Compliance Office programs including monitoring, audits and quality assurance reviews
- Provides oversight and direction for the Clinical Site Monitors, Clinical Site Auditors, and Data Management staff
- Supports the Data and Safety Monitoring Committee (DSMC) by ensuring the Research Compliance Office follows the NCI approved Data and Safety Monitoring Plan
- Reviews and ensures the accuracy of comprehensive reports provided to the DSMC
- Proactively identifies, prioritizes and implements policies and procedural changes to enhance efficiencies of research activities at HCI
- Develops and implements methods, strategies, and standard operating procedures to ensure all compliance needs are met
- Develop, coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues
- Keeps current on new local and federal regulations, rules, revisions, and other industry standards that govern human subject research
- Conducts for-cause and spot audits of clinical trials
- Assists in internal and external audits of research activities
- Collaborates on investigations of matters of suspected non-compliance with appropriate key stakeholders to determine the appropriate corrective and preventative action plan
- Creates metrics to improve performance, efficiency and quality of research activities at HCI
- Participates in projects as assigned to promote research compliance
- Coordinates with Regulatory team when needed to address regulatory-related matters
Problem Solving
This position utilizes federal, institutional guidelines and requirements to inform and complete submission of regulatory documents. This position also negotiates with University research committees and sponsors to ensure full compliance and communication.
The incumbent decides how to best accomplish the daily requirements of various regulatory objectives, prioritizes workload and establishes systems needed to achieve specific goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved following FDA, Good Clinical Practice, IRB, NIH, and/or other regulatory agency guidelines. Incumbent will be responsible for resolving and/or making appropriate recommendations for correction or full resolution to the Director and other members of the management team.
This job description is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Work Environment and Level of Frequency that may be required
Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking.
Seldom: Bending, reaching overhead.
