Scientific Support

• 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.

• 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.
• 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.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

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.

Additional Duties:

• 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