Clinical Studies Specialist

• Member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH guidelines.
• Support clinical team, primarily in tracking, organizing and filing Phase I-IV study documents according to Federal Regulations and ICH guidelines.
• Assist Clinical Team members in handling data queries, drug inventories, study invoice payments, enrollment tracking, and record reconciliation with site documents.
• Assists the CRAs with organizing and planning study investigator meetings.
• Ensure documents are compliant with SOPs and regulatory requirements.
• Review essential/critical documents for completeness and accuracy.
• A Bachelor’s degree is required.
• Pharma experience or professional equivalent is required.
• Strong documentation or research experience
• Multiple TAs. Ability to manage clinical documents for multi-site studies.
• Ability to prioritize multiple tasks and/or projects with limited supervision.
• Ideal candidates will possess strong organizational capabilities and strong interpersonal skills, excellent written and verbal skills.
• Candidates must have a stable work history.
• Foreign MD will be considered only if candidate also has clinical research experience.

All your information will be kept confidential.