Scientific Support

Basic Summary

Responsible for reviewing all study data to ensure it is complete and GLP compliant. Ensure that all data received for review follows SOP and regulatory guidelines that apply to the recording of study data. Interact with Scientist, QA staff and other departments with regards to data.

Essential Duties And Responsibilities

• Complete data review on all paper and electronic data produced in operational departments.
• Ensure all forms that require data review and electronic data are in compliance with Standard Operating Procedures (SOPs) and forms are updated as needed.
• Ensure all data corrections are completed by the appropriate staff members and that they are completed correctly.
• Communicate with department management and Scientist regarding any issues related to data collection that impact the recording of data.
• Assist in departmental training by providing assistance with training on correct methods of data notation and correction as it relates to study data review.
• Assist in revising and developing department forms.
• Archive, collate, and organize all completed and reviewed data and/or file as appropriate.
• Interact with the Scientist regarding data that is received for review. Collaborate with QA staff to ensure GLPs are being followed for the recording of data.
• Assist with department filing as needed.
• Perform all other related duties as assigned.
  
  

Qualifications

• Education: High school diploma or General Education Degree (G.E.D.) required. Associates Degree preferred.
• Experience: None.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None
• Other: Strong organizational, communication and listening skills with acute attention to detail. Basic understanding of processes used for study data collection. Basic understanding of SOPs, FDA GLPs and GCP and other applicable regulatory guidelines governing the recording and review of study data. Basic understanding of algebraic math and scientific concepts. Ability to work effectively as a member of a team. Experienced computer skills; familiarity with Microsoft Office software and specifically with Word and Excel. Ability to work effectively under minimum direction.
  
  

Physical Demands

• Regularly operates a computer and occasionally operates other office productivity machinery such as a label maker, copy machine, and computer printer.
• Regularly communicates with employees.
• Regularly provides information to and receives information from/through various
  
  

technologies, media, sources and contacts. Must be able to exchange accurate information in these situations.

• Specific vision abilities required by this job include close vision and the ability to adjust focus.
• Regularly moves about inside the office to access file cabinets, office machinery, etc.
  
  

Work Environment

• General office and laboratory working conditions, the noise level in the work environment is usually quiet.
  
  

Record observations and measurements and report results for basic to moderately complex lab/research tasks.

Coordinate shipment and receipt of equipment to vendors.

Review data recorded by others for quality control.

Assist technical personnel with clerical duties (e.g., filing, making copies, etc.).

• Assist in the collection and disposal of potentially hazardous material.
• Assist with ordering, receipt and distribution of ordered consumables / lab reagents and complete chain of custody.
  
  

Install and operate basic to moderately complex lab equipment and perform routine maintenance as needed.

May perform limited troubleshooting of instruments as appropriate for assigned area.

Monitor inventory and stock assigned areas.

• May prepare materials and data for routine shipment or archival.
• May be responsible for preparing simple lab solutions (e.g., buffers, media/common vehicles, cleaning solutions).
  
  

May generate reports, data, and forms.

Perform all tasks in compliance with Good Laboratory Practice Regulations (GLPs) and Standard Operating Procedures (SOPs).

Perform all other related duties as assigned

The max pay rate is 22/hr for this position