UNIV-Research Regulatory Specialist-Hollings Cancer Center

MUSC Health; Charleston (SC); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player in healthcare is seeking a detail-oriented Regulatory Specialist for its Hollings Cancer Center. This role involves managing regulatory submissions, ensuring compliance with quality assurance standards, and supporting monitor visits. The ideal candidate will thrive in a dynamic work environment that encourages growth and development. With a focus on regulatory excellence, this position is perfect for someone passionate about supporting clinical research and making a significant impact in patient care. Join a team dedicated to advancing healthcare and ensuring the highest standards of regulatory compliance.

Qualifications

• Bachelor's degree and two years of relevant experience required.
• Experience in regulatory submissions and document management is essential.

Responsibilities

• Manage submissions for reportable events and renewals.
• Conduct quality assurance checks and prepare for audits.
• Schedule and coordinate monitor visits with stakeholders.

Skills

Regulatory Submissions Management

Quality Assurance

Document Management

Stakeholder Communication

Data Entry

Education

Bachelor's Degree

Tools

OnCore

Job description

UNIV-Research Regulatory Specialist-Hollings Cancer Center

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Job Description Summary

Under the supervision 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

See detailed job description below

Job Description

1. Regulatory Submissions (30%): Manage submissions for reportable events, renewals, and local changes, including IRB approvals, tracking within OnCore, and preparing personnel credentials.
2. Document Management & QA (30%): Conduct quality assurance checks, prepare for audits, transition documents to electronic systems, and ensure compliance with GCP guidelines.
3. Monitor Visit Support (30%): Schedule and coordinate monitor visits, communicate with stakeholders, and document visit activities.
4. Unit Support & Education (10%): Support data entry, participate in training, and contribute to process improvements.

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 lifting up to 15 lbs, working indoors and outdoors, and visual and auditory acuity.

Additional Information

We offer a dynamic work environment with opportunities for growth and development. MUSC is an Equal Opportunity Employer and participates in E-Verify.