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Regulatory Specialist (Remote)

Job Title
Regulatory Specialist (Remote)
Job ID
27651979
Work From Home
Yes
Location
Austin,  TX 78738
Other Location
Description
JOB SUMMARY

The Study Start-Up Regulatory Specialist plays a key role in the quality and regulatory compliance of Essential Documents and the eISF during start-up for each Study Site Unit (SSU) and/or Decentralized Clinical Trial.
RESPONSIBILITIES
  • Maintains confidentiality, prioritizes, and manages work effectively and provides exceptional customer service internally and externally
  • Liaises with Site, Client, and IRB throughout the study to assist with regulatory study start-up, including:
    • Receipt, organization and filing of essential documents
    • Processing of IRB submissions, approvals and corresponding documents
    • Performing quality reviews of the eISF
  • Ensures preparation of the eISF prior to SIV/Green Light
  • Gathers, enters and/or updates data to maintain company records and databases
  • Performs other duties and responsibilities, as required
QUALIFICATION AND EDUCATION REQUIREMENTS
 
  • Highly experienced in Clinical Research Trials and set up of an eISF
  • Efficient with strong organization and prioritization skills for the management of multiple concurrent projects
  • Possess temperament and emotional intelligence for dealing with others professionally
  • Ability to maintain professionalism and professional standards
  • Identify and resolve problems effectively and efficiently
  • Strong technical knowledge of systems or applications
  • Demonstrates ability in positive relationship building, with strong verbal and written skills
  • Ability to work well under timelines and deliverable targets
  • Strong interpersonal skills with attention to detail
  • Demonstrates proficiency with MS Office software such as Outlook, Word, Excel, PowerPoint, SharePoint)
  • Knowledgeable of FDA, GCP, and NIH guidelines
  • Experienced with Central IRBs

WORKING CONDITIONS

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status.

No travel is required for this position.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position.  They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel.  More in-depth information can be found in SOP's, working guidelines, policies, etc.

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.

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