Clinical Project Associate I
Location: Foster City, CA
Name: Jizelle Joson
The position entails work under general supervision for routine tasks and with detailed instructions on new assignments. Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools. Provide input and assist with harmonization of Clinical Operations databases and tracking tools. Assist in the maintaining clinical information and training of Clinical Operations personnel in the clinical trials database (GILDA). Tracks and files documents in the Trial Master File (TMF). Processes drug shipments, drug returns, and assists with in-house drug reconciliation. Orders and maintains inventory of clinical supplies. Orders and ships case report forms. Assists with development of documents for site binders and assembles and prepares distribution of site binders. Serves as CRA back up providing verbal and written communication with study personnel. Under close supervision reviews and participates in the quality assurance of data or documents. Arranges meeting logistics. Drafts meeting agendas and assists in preparing meeting minutes. (Interacts with other departments, as directed, to complete assigned tasks.) May assist with monitoring visits under the direct supervision of senior staff. Travel may be required. Excellent verbal and written communication skills and interpersonal skills are required. Must be familiar with Word, PowerPoint, and Excel. Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus. Must be able to work both independently and as part of a team.
- top 3 skill-sets desired (attention to detail, time management)
- Liver disease (Hepatitis C Disease and NASH) studies
- might be working on closeout study tasks
- this person may be working on ad hoc time sensitive studies
- this person should be flexible in that matter
- will be looking at reconciling distribution lists (making sure the list is current)
- will be looking at the documents in the TMF and the study tracker
- no travel
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.