Sr. Clinical Trial Associate

Job Title: Sr. Clinical Trial Associate (CTA)

Remote

Pay rate: $40/hr depending upon degree and education

Description: Clinical Trial Associate, Clinical Operations will be responsible to perform tracking, develop spreadsheets, file documentation (Box / eTMF), and provide support for the Clinical Team.

Responsibilities

• Supporting the Study Lead, Project Manager, Clinical Research Associates and Team in the management of clinical trial projects
• Preparation and maintenance of the Trial Master Files (eTMF) and Investigator Site Files
• Develop processes to track and optimize clinical activities for Abeona clinical studies
• Management of shipment/retrieval of study materials
• Assist the Clinical Study Leads by providing support to Investigator and Team meetings
• Site assistance with regulatory and IRB document preparation and tracking
• Assists in the communication / logistics between internal and external team members to ensure current program status and priorities are on track
• Recognizes potential challenges and supports the Team in problem solving to assist in the resolution or escalation as appropriate
• Cooperate with different departments to improve business operations
  
  

Qualifications:

• University/College Degree (BS/BA)
• Minimum 6 years relevant experience in Clinical Research for a Sponsor or CRO
• Demonstrated experience managing projects
• Progression of clinical trial experience in the pharmaceutical field
  
  

Experience and Skills: Ability to manage multiple projects and shifting priorities. Previous exposure to drug/biological/therapeutic research, particularly in gene therapy is a plus. Good working knowledge in Good Clinical Practice and ICH Guidelines. Effective communication (written and verbal), strong interpersonal, and organizational skills. Must have the ability to function independently, multitask, be flexible, detail oriented, and work effectively on a team with a high degree of professionalism. Must have experience in effectively troubleshooting and resolving clinical issues. Computer skills (MS Office, MS Project, EDC, eTMF, etc.).