Job Description
Job DescriptionSalary:
Reporting to the a Clinical Trial Lead, 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
Bachelors 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