Senior Specialist, Regulatory Operations

Job not on LinkedIn

🕒 5 days ago

🇺🇸 United States – Remote

💵 $90k - $100k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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CARE

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1945

⚕️ Healthcare Insurance

📚 Education

🎯 Recruiter

💰 Grant on 2021-11

Healthcare Insurance • Education • Recruitment

CARE is a boutique provider of high-quality, accredited carers for the Aged Care and Early Learning industries. It specializes in matching experienced professionals, recent graduates, and students with job vacancies in these sectors, facilitating rewarding career placements. CARE aims to support clients and carers by providing effective staffing solutions and contributing to their success in the industry.

📋 Description

• Provide regulatory advice, lead, execute and deliver regulatory project work • Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, OHRP and global regulatory standards. • Assist in preparing for sponsor monitoring visits and follow up requirements. • Develop and implement regulatory strategies to support sites activities • Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices. • Coordinates preparation and review of key site essential records. • Track essential records and timelines • Support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout. • Actively work towards KPIs to help ensure departmental success • Supports creation and maintenance of study Delegation of Authority (DOA) logs • Monitor and interpret changes in U.S. regulatory policies and guidelines, advising internal stakeholder on potential impacts.

🎯 Requirements

• Minimum of 4 years of experience in operational regulatory affairs within the research site (preferable), or CRO/pharmaceutical industry, with a focus on U.S. regulatory requirements. • Strong understanding of U.S. regulations and ICH GCP guideline as they relate to site operations • Excellent knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in the U.S. • Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance. • Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience.

🏖️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays • 100% Employer paid medical, dental, and vision insurance plan options • Health Savings Account and Flexible Spending Accounts • Bi-weekly HSA employer contribution • Company paid Short-Term Disability and Long-Term Disability • 401(k) Retirement Plan, with Company Match