Clinical Research Regulatory Specialist – Remote

Inside Higher Ed; Philadelphia (Philadelphia County); Hybrid; USD 62,000 - 70,119; Full time

Benefits offered by this job

Health, Life, and Flexible Spending Accounts

Tuition assistance

Generous retirement plans

Paid time off

Flexible schedules

Long-term care insurance

Wellness resources

Professional development resources

Access to cultural activities

Discounts for staff

Job summary

A leading cancer research institution in Philadelphia seeks a full-time Clinical Research Regulatory Specialist to coordinate Phase I-V clinical trials. The role involves preparing regulatory documentation, facilitating FDA applications, and providing regulatory guidance. Ideal candidates possess a Bachelor's degree and relevant research experience, along with strong communication and problem-solving skills. The position offers a salary range of $62,000 to $70,119 with various benefits including health insurance and tuition assistance.

Qualifications

• 3-5 years research experience or equivalent combination.
• 1 year regulatory experience preferred.
• Experience in high-risk biomedical research preferred.

Responsibilities

• Prepare and process all regulatory documentation.
• Resolve regulatory and data queries.
• Facilitate FDA IND applications and maintain documents.

Skills

Problem solving

Critical thinking

Strong communication

Time management

Teamwork

Knowledge of IRB regulations

Detail-oriented

Microsoft Office

Web-based e-regulatory systems

Education

Bachelor's degree in life science or related field

Tools

Microsoft Office

Slack

Teams

Zoom

WebEx

eFlorence

Veeva

Job description

A leading cancer research institution in Philadelphia seeks a full-time Clinical Research Regulatory Specialist to coordinate Phase I-V clinical trials. The role involves preparing regulatory documentation, facilitating FDA applications, and providing regulatory guidance. Ideal candidates possess a Bachelor's degree and relevant research experience, along with strong communication and problem-solving skills. The position offers a salary range of $62,000 to $70,119 with various benefits including health insurance and tuition assistance.