UNIV-Research Regulatory Specialist-Hollings Cancer Center

Medical University of South Carolina; Charleston (SC); On-site; USD 38,000 - 73,000; Full time

Job summary

Join a forward-thinking institution dedicated to advancing healthcare through innovative clinical trials. This role is pivotal in overseeing regulatory activities, ensuring compliance, and managing project timelines for oncology studies. You will collaborate with a dynamic team, driving high-quality performance and contributing to impactful research. If you thrive in a fast-paced environment and are passionate about making a difference in cancer care, this opportunity is perfect for you. Enjoy a rewarding career with enthusiastic colleagues committed to excellence and patient-centered outcomes.

Qualifications

• Minimum two years of relevant experience in regulatory management.
• Ability to manage timelines and ensure compliance with regulatory standards.

Responsibilities

• Oversee study start-up processes and manage timelines for clinical trials.
• Prepare and submit IRB applications, ensuring compliance with policies.
• Complete regulatory documentation and maintain accurate records.

Skills

Regulatory Knowledge

Project Management

Communication Skills

Data Analysis

Education

Bachelor's Degree

Job description

Job Description Summary

Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. Oversees the regulatory activities for federal, corporate, and institutional research projects submitted and activated at the Hollings Cancer Center, promoting high-quality and efficient regulatory performance as required by the NCI Core Grant.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type

Classified

Cost Center

CC001332 HCC CTO Administration

Pay Rate Type

Hourly

Pay Grade

University-05

Pay Range

38,985.00 - 55,559.50 - 72,134.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Study Start-up Reporting and Activation Project Management 35%

• Oversees the study start-up process and manages timelines for oncology clinical trials within Hollings Cancer Center Disease Focus Groups (DFG). Ensures timely activation aiming for an average of 90 days from Protocol Review Committee (PRC) submission, with accurate input into the Clinical Trials Data System.
• Maintains OnCore updates, monitors milestones, reports project updates, and escalates issues exceeding NCI CCSG metrics.
• Interfaces with MUSC, sponsor, and CRO leads to prioritize document creation and ensure deadlines are met.
• Prepares protocol submission forms for scientific review and participates in meetings to provide input and follow-up.
• Communicates regulatory requirements and provides data to DFG leaders for trend analysis.

IRB Application and Document Management 35%

• Prepares, submits, follows up, and communicates all IRB submissions, amendments, and renewals from initial application to termination.
• Tracks IRB submissions, collaborates on informed consent documents, and ensures compliance with policies.
• Determines appropriate IRB of record, manages study updates, and prepares responses to IRB requests.
• Organizes study documents and communicates updates to investigators and teams.

Approval Processing and Quality Assurance 25%

• Completes regulatory documentation required by sponsors, maintains accurate records, and applies regulatory knowledge to daily operations.
• Creates and maintains regulatory documents, supports monitoring visits, and addresses findings or deficiencies promptly.

Regulatory Unit Support and Continuing Education 5%

• Participates in training, regulatory coverage planning, and team meetings. Maintains relationships with sponsors/CROs.

Additional Job Requirements

Minimum requirements include a bachelor's degree and two years of relevant experience. The physical and sensory requirements necessary for the role are detailed, including ability to perform job functions in various positions, work indoors and outdoors, and meet vision and hearing standards.

If you enjoy working with energetic, enthusiastic individuals, you will find a rewarding career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, age, sex, national origin, gender identity, sexual orientation, disability, veteran status, or other protected categories. All qualified applicants are encouraged to apply.

Participation in the federal E-Verify program is required for all new hires. More information can be found at http://www.uscis.gov/e-verify/employees.