UNIV - Research Regulatory Specialist - Hollings Cancer Center

Medical University of South Carolina • Charleston, SC

117d • $39,764 - $73,576

About The Position

Under the supervision and management of the regulatory unit program manager, this position will oversee post activation activities managed by the HCC CTO within MUSC. The role involves managing the study start-up process and ensuring compliance with regulatory requirements for oncology clinical trials. The position requires effective communication with various stakeholders and meticulous documentation of all regulatory submissions and approvals.

Requirements

• A bachelor's degree.
• Two years of relevant program experience.
• Proficient with IRB of record submissions for MUSC, WIRB, Advarra, NCI CIRB, and other IRBs.

Responsibilities

• Oversee the study start-up process and manage the start-up timeline of all oncology clinical trials assigned within the respective Hollings Cancer Center Disease Focus Group(s).
• Ensure timely and accurate input of required study start-up milestones into the Clinical Trials Data System.
• Monitor start-up milestones across the HCC Clinical Trials Office, DFG, and PRC, and report project updates.
• Interface with relevant MUSC, sponsor, and Clinical Research Organization functional leads to prioritize essential document creation.
• Complete the protocol submission form in the Protocol Review Committee portal.
• Prepare, submit, and follow up on all IRB submissions from initial application through termination.
• Track IRB submissions and collaborate with sponsors/CROs to develop compliant informed consent documents.
• Complete sponsor-required regulatory documentation and maintain accurate documentation as required by the sponsor.
• Assist with sponsor and internal monitoring visits and provide regulatory support.
• Participate in training curriculum and continuing education for employees.

Benefits

• Hourly pay rate between $39,764.00 - $73,576.00.
• Scheduled weekly hours of 40.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees