UNIV-Research Regulatory Specialist-Hollings Cancer Center

Medical University of South Carolina; Charleston (SC); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a detail-oriented professional to oversee regulatory activities within a vibrant team. This role involves managing submissions for reportable events, conducting quality assurance checks, and ensuring compliance with regulatory requirements. If you thrive in a dynamic environment and enjoy collaborating with enthusiastic individuals, this position offers an exciting opportunity to contribute to impactful projects in the healthcare sector. Join a team dedicated to excellence and make a difference in the lives of others.

Qualifications

• Bachelor's degree and two years of relevant experience required.
• Ability to perform job functions in various physical positions.

Responsibilities

• Prepare submissions for reportable events and manage IRB applications.
• Conduct quality assurance checks and maintain study documentation.
• Schedule monitor visits and ensure findings are addressed.

Skills

Regulatory Submissions

Quality Assurance

Document Management

Stakeholder Communication

Education

Bachelor's Degree

Tools

OnCore

eReg

SPARC

Job description

Job Description Summary

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.

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

1. Regulatory Submissions (30%): Prepare submissions for reportable events, renewals, and local changes. Manage IRB applications, track expirations, and update study and personnel documentation in systems like OnCore, eReg, and SPARC. Communicate regulatory requirements effectively.
2. Regulatory Document Management & QA (30%): Conduct quality assurance checks, prepare for audits, maintain study documentation per GCP guidelines, and support transition of documents to electronic systems.
3. Monitor Visit Scheduling & Support (30%): Schedule monitor visits, communicate with stakeholders, prepare visit documentation, and ensure findings are addressed.
4. Unit Support & Education (10%): Assist in data entry, participate in training, support process improvements, and maintain relationships with sponsors and CROs.

Minimum Requirements: Bachelor's degree and two years of relevant experience.

Physical Requirements: Ability to perform job functions in various physical positions and conditions, including standing, sitting, walking, and working in different environments, with specified weight and vision capabilities.

If you enjoy working with energetic, enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer, participating in the E-Verify program. For more information, visit http://www.uscis.gov/e-verify/employees.