Job Details

Description:

The Senior Clinical Trial Associate (CTA) supports the Clinical Operations department in the planning, execution, and management of in-house or outsourced clinical trials. The Senior CTA will review; track and file study specific documents as well as create and update study specific reports. They must exercise discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks. Must have the ability to balance changing priorities. 

Experience:
 

• Bachelor’s degree in life sciences or healthcare related field
• 3+ years of experience working in the pharmaceutical / biotech industry

Responsibilities:
 

• Take minutes for clinical trial insurance meetings and file minutes and relevant documents (ICFs, country insurance policies, certificates etc.)
• Coordinate and track the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visits reports etc.  Subsequently, file all regulatory required documents into the Trial Master Files.
• Maintain and ensure all documentation is in a state of audit readiness.
• Maintenance of the Trial Master File and electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs.
• Assist in the preparation of study related documents, i.e., ICF, clinical trial tools & templates etc.
• Coordinate and track clinical trial equipment and supplies, when appropriate.
• Review and track vendor invoices against contracts and coordinate approval.
• Assist with site budget process.
• Support the trial team to produce and distribute study newsletters.
• Create agendas and record team meeting minutes under the direction of the Clinical Trial Manager. Subsequently, update study dashboards on bi-weekly basis
• Assist the Clinical Trial Manager with timeline maintenance.
• Provide administrative assistance to the clinical team as needed, such as booking meetings and conference rooms, assisting with expense as requested, other administrative assistance as needed.

Key Skills:
 

• Solid understanding of the responsibilities and needs of other functions in a clinical trial
• Strong computer skills including knowledge of MS Excel, Word, PowerPoint, and Outlook   
• Proven ability to work independently, and effectively handle multiple priorities in a fast-paced environment
• Ability to maintain confidentiality of proprietary information expected
• A team player that takes initiative 
• Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization
• Proficient written and verbal communication skills.