CLINICAL RESEARCH REGULATORY COORDINATOR II

The University of Alabama at Birmingham (UAB), General Internal Med & Population Science, is seeking a Clinical Research Regulatory Coordinator II.

This position will support activities of multiple research projects including pilot and feasibility projects, R01 randomized trials, and the work of a P50-funded center. Most projects involve social science, behavioral medicine, or community-based interventions addressing prevention and management of cardiometabolic health concerns and chronic disease throughout the lifespan. Someone in this position will need to be highly organized and methodical, able to track the progress of multiple projects. The ideal candidate would display experience and knowledge of IRB regulations, be self-motivated, and see themselves as a guide and help to those starting careers in research. An interest in and willingness to learn new tools for tracking and reporting will be helpful.

General Responsibilities

• To prepare, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• To maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
• To draft informed consents.
• To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
• To assist in drafting compliant advertisements.
• To serve as resource person or act as consultant within area of regulatory expertise.

Key Duties & Responsibilities

1. Provides oversight and training to study team members (including early-stage investigators) who maintain participant-level documentation such as consent records and enrollment logs and will maintain study-level documentation.
2. Provides direction to study teams preparing for monitoring or audit visits and assists in addressing any findings.
3. Develops UAB IRB documents (consent forms, protocols/ePortfolio, continuing reviews, amendments) and will train other staff in these tasks.
4. Tracks and maintains training requirements and develops systems to ensure study team members' compliance.
5. Responsible for registering and maintaining study records on ClinicalTrials.gov. At the end of a study, they will take part in or lead closeout and document storage activities.
6. Responsible for assisting in the development of research proposals or protocols, specifically regarding regulatory methods and the subsequent implementation of the protocols. For example, the individual will be expected to identify when data agreements are necessary and will assist in the development of documents, systems, and training manuals for standard operating procedures.
7. Detects issues with data collection or management and works with other team members to improve systems. They will also use system reports to ensure unit compliance with institutional requirements/policies and may assist team members with understanding these requirements and policies.
8. Contributes to the preparation and submission of progress reports in eRA Commons/ASSIST.
9. Familiar with the ethical conduct of research, safeguards needed when conducting research with vulnerable populations, and know that the safety of research participants is a priority.
10. Recognizes and employs the professional guidelines and code of ethics related to the conduct of clinical research.
11. Responsible for coordinating the documentation and reporting process of adverse events according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently, as well as developing documents and reports that will be including in regular safety monitoring.
12. Participates in study team meetings, responds to routine questions related to study protocol, and refers more complex questions to others as appropriate, can communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
13. Encourages and supports colleagues in completing project work and assist research colleagues in identifying efficiencies and improving process.
14. Performs other duties as assigned.

Annual Salary Range: $47,665 - $77,455

Qualifications

Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.

Preferences

• Good communicator
• Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.