Clinical Trial Associate/ Sr. CTA
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Overview
Job Description
The Clinical Trial Associate supports the clinical team with management, planning and implementing clinical research studies within the development life-cycle, evaluating and analyzing clinical data, as well as supporting oversight of vendors for execution of studies. The successful candidate will assist the Clinical Project Managers in the conduct of trials and may be responsible for managing portions of a trial, such as startup activities, vendor communication, as assigned.
Responsibilities:
● Assist Clinical Project Manager (CPM) in site management activities which could include review of monitoring report, tracking of site visits, communication with monitors and sites, and other activities as assigned, or track vendor metrics of these activities, if outsourced
● Prepare and participate in investigator meetings training, and facilitate vendor performance and tracking of these activities
● Participate in review of packages for initial EC/IRB submissions
● Oversight of site payment processing by tracking confidentiality agreements, site and vendor contracts and payments
● May participate in the training of vendor teams, investigators and staff as needed regarding assigned logistics of the clinical trial
● Maintain study documentation according to ICH guidelines and SOPs
● Assist the team in preparation for audits or inspections
● Maintain monthly statistics on participant status and monthly report of clinical research activities
● Communicate with CRO or other vendors, as applicable, and assist with tracking study metrics
Qualifications:
● Bachelor's Degree.
● 0-3 years of experience in clinical research
● Basic understanding of drug development process including phases of clinical studies and the role of post-marketing studies in the development plan
● Understand interactions between sponsor, investigator, ethics committees and regulatory agencies
● Basic understanding of medical terminology and components of medical records by applying knowledge appropriately while reviewing and creating document
● Builds productive working relationships internally and externally
● Strong computer skills (Microsoft Office Word, Excel, Outlook) required
● Strong oral and written communication skills
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