About Rare Disease Research:

As an independent clinical research site, we are 100% dedicated to conducting clinical research, accelerating the development of safe and effective treatments and providing rare disease patients with access to innovative investigational therapies. We are a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.

About This Opportunity:

We are looking for a Regulatory Assistant to join our wonderful team of motivated research professionals. The Regulatory Assistant position plays an important role at Rare Disease Research by helping the team in compliance with regulatory requirements and guidelines governing clinical research studies. The main responsibilities are to assist the team with:

• Regulatory Compliance: Ensure adherence to regulatory requirements set forth by governing bodies such as the FDA, ICH-GCP, and institutional review boards (IRBs)
• Documentation Preparation: Prepare, review, and submit regulatory documents such as study protocols, informed consent forms, investigator brochures, and annual reports to regulatory agencies and IRBs
• Study Start-Up: Facilitate the initiation of clinical trials by obtaining necessary regulatory approvals and ensuring all essential documents are in place before study commencement
• Monitoring and Auditing: Assist in internal and external audits by maintaining accurate and organized regulatory files and providing requested documentation and information
• Communication: Serve as a liaison between research teams, regulatory authorities, and sponsors, providing updates on regulatory requirements and ensuring timely submission of documents
• Record Keeping: Maintain comprehensive and up-to-date regulatory files and databases, including tracking submissions, approvals, and correspondence related to each clinical trial

The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.

Requirements:

• Associate or Bachelor’s Degree (BS/BA preferred)
• 6 months to 1 year experience in clinical research coordination or regulatory affairs preferred
• Excellent organizational, communication and computer skills
• Meticulous attention to detail
• Ability to work independently and collaboratively in a diverse and fast-paced environment
• BLS/CPR training upon hire date
• Please note that due to the immunocompromised nature of our patients, COVID and annual flu vaccinations are required

Job Type: Full-time

Pay: $20 - $24/hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday, fully in-person, onsite

Rare Disease Research is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, or any other characteristic protected by federal, state or local laws.

Notice To Third-Party Agencies:

Rare Disease Research does not accept unsolicited resumes from recruiters or agencies. Any staffing/employment agency, person or entity that submits an unsolicited resume to this site does so with the understanding that the applicant's resume will become the property of Rare Disease Research will have the right to hire that applicant at its discretion and without any fee owed to the submitting staffing/employment agency, person, or entity.

Job Type: Full-time

Pay: $21.00 - $24.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Paid parental leave
• Paid time off
• Vision insurance

Experience level:

• 1 year

Schedule:

• Monday to Friday

Ability to Relocate:

• Brookhaven, GA 30329: Relocate before starting work (Required)

Work Location: In person