Job Description

The Clinical Trials Assistant will provide general project assistance to the clinical trial teams. You will perform administrative duties as assigned by the project manager that may include internal/external communications, writing meeting minutes, filing trial documents into the Trial Master File system (eTMF on Sharepoint), and preparing site binders and material shipment. You will also have study coordination duties related to study start up activity, study data monitoring activity, product accountability and escalating issues to the PM.

J OB FUNCTIONS

• Customize and track contracts (drafted and standardized by the sponsor) for sites (dermatologist offices) during study start up
• Arrange internal and external meetings (physical or online) with sites for Site Initiation Visits (SIVs)/ trainings/ escalation follow ups under the direction / supervision of PM. Produce minutes from the meetings.
• Managing the eTMF (study SharePoint) during study start up and execution and upload documents in the sponsor’s document management system, if applicable. Track and file ICH-GCP certifications, essential study documents
  • Assist in collecting essential documents from sites for the Institutional Review Board (IRB) submission packages
• Prepare the Investigator Level Binder and Site Initiation Visit materials for each site
• Data monitoring - Check on queries (data being out of range, items not being marked as completed for a completed visit, etc). Regularly send out list of compiled queries for sites to resolve and escalate as needed.
• Keep an up-to-date subject log (tracking enrolled vs drops)
• Send newsletters to the participating investigators, if applicable
• Organize and document the shipment of study documents and supplies to the participating sites

Qualifications

EDUCATION AND EXPERIENCE

• Bachelor's degree in a relevant field Preferred
• 2+ years of relevant experience in Clinical Trials/Research Preferred

WORK LOCATION
Please note, this position is based on-site at our offices in Richardson, TX or Phoenix, AZ. Remote or hybrid work arrangements are not available for this role. Candidates must be able to reliably commute to and work from one of these locations.

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.