Clinical Trial Disclosure Associate

Title: Clinical Trial Disclosure Associate

Location: Remote

Compensation: $40-$49/hr. open depending on experience and education

Shift: 1st shift, Mon.-Fri.

Essential Duties and Responsibilities:

• Completes activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
• Continually trains/is compliant with all current SOPs & work instructions.
• Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
• Coordinates the review, approval, and other appropriate functions.
• Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
• Communicates deliverables, process and timelines effectively across functional areas and within department to accomplish project objectives.
• Identifies conflicts and resolves or elevates them to management to ensure resolution.
• Responsibilities will vary based upon business need. May support global study registrations, writing scientific study results, protocol / result lay summaries, or anonymizing clinical documents for public disclosure by regulatory agencies.
• Responsibilities will be focused on supporting EU CTR applications and documentation. Familiarity with clinical study and site start up documentation is preferred.

Qualifications:

• Bachelor's degree required, preferably in a health or biological science field
• 2-4 yrs experience in clinical trial registries, regulatory agency transparency or drug development with a clinical research, quality or regulatory background, preferably in a pharma environment
• Attention to detail. Find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
• Ability to shift daily priorities, meet deadlines, ask questions
• Project management experience preferred
• Proficient with major Microsoft suite programs and other pharma systems
• Works well in a global, team environment
• 2 years of writing experience preferred