Clinical Studies Specialist II (GMP Documentation, SOPs)

HYBRID; MUST BE ONSITE TUES/WED/THURS

PAY: $30-34/HR

REQUIRED:

• AS OR BS and 1 years of experince with GMP documentation and SOPs.
• MS Excel required
• Smartsheets and Adobe highly preferred
• Clinical labeling a plus
• Data entry and document review experience
• Strong organizational, time management, and prioritization skills

Job Description:

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.

This position operates in a highly regulated environment and requires excellent organizational and time management skills, strong written and verbal communication skills, and the ability to follow detailed instructions and established processes. The successful candidate must be dependable, self-motivated, able to work independently, and also function effectively as part of a team. The ability to adjust priorities on short notice in response to changing business needs is critical.

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

• 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