This role involves reviewing and ensuring compliance with regulatory and billing standards for industry and government-sponsored clinical trials.
Responsibilities include preparing IRB submissions, managing study documentation, and coordinating with billing departments.
Qualifications require a relevant degree and experience in regulatory processes and patient billing, with certification as a Research Professional preferred.
Core duties encompass IRB application writing, protocol amendments, safety reporting, and communication with investigators and sponsors.
Skills include regulatory knowledge, problem-solving, teamwork, time management, and computer proficiency.
Physical demands involve office tasks and occasional patient contact in a clinical environment.
Work hours are 40/week, day shift, with an emphasis on compliance, documentation, and collaboration. Candidates should demonstrate strong organizational and communication skills, adaptability, and attention to detail.