CLINICAL RESEARCH REGULATORY COORDINATOR I

The University of Alabama at Birmingham (UAB), Department Ped - Hematology/Oncology , is seeking a Clinical Research Regulatory Coordinator I.

General Responsibilities

• To assist in maintaining regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
• To assist with preparation of Institutional Review Board (IRB) submissions including preparing all relevant documentation and obtaining necessary signatures to meet study timelines.
• To assist with initial drafts of informed consent documents.
• To prepare regulatory binders and associated documentation.

Key Duties & Responsibilities

1. Enters protocol specific data into required institutional systems (IRAP and OnCore).
2. Maintains Delegation of Authority logs.
3. Tracks and maintains documentation of training, medical licenses, CVs, etc. for key personnel.
4. Updates investigator registrations in the CTEP RCR system.
5. Assists with registration membership for new employees with Children's Oncology Group, CTEP RCR, and other external systems.
6. Scans and archives paper regulatory documents.
7. Performs other duties as assigned .

Hourly Range: $18.85 - $30.65

Qualifications

High School diploma or GED required.

UAB is an Equal Opportunity/Affirmative Action Employer committed to fostering a diverse, equitable, and family-friendly environment in which all faculty and staff can excel and achieve work/life balance irrespective of race, national origin, age, genetic or family medical history, gender, faith, gender identity and expression as well as sexual orientation. UAB also encourages applications from individuals with disabilities and veterans.