JOB DESCRIPTION

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Employee performs all, part, and/or any combination of the duties listed below.

• Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities.
• 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.
• Supports in the development and adaptation of country/site specific informed consent forms.
• 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.
• Ensures the TMF file structure follows applicable company approved TMF configuration, with reference to ICH Guidelines for Good Clinical Practice, Good Documentation Practices, and the DIA TMF Reference Model, as required.
• Maintain knowledge of and understand Lotus CRO SOPs, Client SOPs/directives, and current regulatory guidelines as applicable.
• Resolution of Regulatory action items (i.e., audit findings, QC findings, etc.) throughout the course of the study.

SUPERVISORY RESPONSIBILITIES

Position supervises the Regulatory Coordinator and Clinical Trial Assistant and has responsibility of workflow supervision of staff. Provides guidance and assistance, as needed.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION and/or EXPERIENCE

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

SKILLS and/or ABILITIES

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.