Job description

Why Join Us?

Lotus is a reputable, collaborative Clinical Research Organization that will guide you in your career. Lotus offers career development, leadership opportunities, and encourages our employees to meet their personal and career goals. As a smaller organization, we ensure a cooperative environment where individual voices and contributions make a difference and are valued. We offer a competitive salary based on experience and a range of benefits including medical, dental, vision, 401k, and PTO.

P*urpose of the Role: *

The Regulatory Operations Specialist will provide regulatory support for all studies being managed by Lotus Clinical Research as a CRO and for all studies being conducted at Lotus Clinical Research as a site through the planning and execution of all IRB submissions to ensure compliance to all Federal Regulations.

Job Responsibilities:

Communicates with relevant functional leads to ensure appropriate prioritization of essential document collection and review to facilitate synchronized start-up

Responsible for creating Regulatory templates (i.e., FDA form 1572, protocol signature page, etc.)

Collect, receive, and perform first review of required study-specific site regulatory/essential in accordance with applicable SOPs, guidelines, and relevant study specific plans. Implement corrective action as needed, prior to essential document review and sign off.

Key-contact and responsible for country and site level Ethical or Regulatory submission-related activities.

Plans, schedules, and conducts internal Quality Control (QC) Reviews of the TMF in coordination with relevant functional leads.

Accountable for the overall TMF quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, including third party documents, TMF tracking, auditing, and reporting.

Resolution of Regulatory action items (i.e., audit findings, QC findings, etc.) throughout the course of the study.

Education/Experience:

Bachelor’s degree or equivalent education/degree in life science/healthcare is required

1-2 years of IRB submission experience. Clinical research experience preferred.

Skills:

Ability to enter data into PC accurately, including experience working with Microsoft Office.

Ability to work effectively and efficiently handling multiple tasks simultaneously.

Ability to facilitate a teamwork philosophy with a positive attitude.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday
• Night shift
• Weekend availability

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