Position Title: Clinical Studies Specialist - Clinical Labeling
Work Location: North Chicago, IL 60064
Assignment Duration: 6 Months (possible extension)
Work Arrangement: Onsite
 
Position Summary:
This contractor position supports the creation, transfer, review, and coordination of clinical labels for clinical supplies used in clinical studies. The role requires exceptional attention to detail, strong computer proficiency, and the ability to quickly learn and apply new systems and processes. A high degree of accuracy in data entry and document handling is essential.
 
Background & Context:
This position supports the Clinical Labeling Support Team, which is responsible for creating, reviewing, proofreading, and maintaining clinical study labels in a regulated GMP environment. The contractor will primarily support the team during the transition from one labeling system to another by assisting with the migration of information between the two systems.
 
Key Responsibilities:

• Transfer clinical labels into a new system
• Create and design clinical labels according to established requirements
• Proofread label proofs to ensure accuracy and compliance
• Coordinate labeling documentation and related approvals
• Support additional labeling-related projects as needed
• Additional Responsibilities, if the Contractor Proves Successful:
• Manage assigned labels and studies independently
• Create labels using source documents and global regulatory requirements, ensuring information is complete, consistent, and accurate
• Communicate and coordinate labeling and documentation activities with worldwide affiliates
• Maintain professional communication with internal business partners and global stakeholders

 
Qualifications & Experience:

• Proficient computer skills and ability to quickly learn new software and systems
• Data entry experience with a high degree of accuracy
• Strong attention to detail and organizational skills
• Excellent written and verbal communication skills
• Ability to work independently with minimal supervision
• Ability to collaborate effectively as part of a team
• Strong time management skills and ability to manage multiple priorities
• Comfortable working in a highly regulated environment
• Able to follow detailed instructions and established procedures
• Flexible and responsive to changing priorities and business needs
• High attention to detail with the ability to consistently produce accurate work
• Ability to work independently while also collaborating effectively as part of a team
• Strong time management skills with the ability to manage a high workload, multitask, and transition between multiple projects without mixing information between projects
• Dependable, self-motivated, and able to quickly learn new systems and processes
• Ability to quickly learn and apply new information after training
• Experience performing data entry with a high degree of accuracy
• Previous experience working in a GMP (Good Manufacturing Practice) environment is preferred
• Strong computer proficiency with the ability to quickly learn new software and systems
• An analytical background is preferred
• Experience interpreting protocols, source documentation, analytical documentation, and following Standard Operating Procedures (SOPs)
• Experience using Microsoft Excel is preferred
• Experience using Smartsheet or similar tracking tools is beneficial
• Experience using label design software or similar design applications is beneficial
• Candidates with a High School Diploma, associate’s degree, or bachelor’s degree will be considered if they possess the required skills and experience

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $29.00/hr - $32.00/hr.