Clinical Project Associate Job Description Template
Our company is looking for a Clinical Project Associate to join our team.
Responsibilities:
- Arranges meeting logistics;
- Interacts with other departments, as directed, to complete assigned tasks;
- Drafts meeting agendas and assists in preparing meeting minutes;
- Under close supervision reviews and participates in the quality assurance of data or documents;
- Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools;
- May lead two or more specific components of departmental strategic initiatives;
- Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols;
- With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans;
- Participates in protocol review discussions concerning scientific and procedural aspects of study design;
- Assists with management of the electronic trial master file;
- Orders and maintains inventory of clinical supplies;
- Serves as CRA back up providing verbal and written communication with study personnel;
- Assists with development of documents for site binders;
- Processes drug shipments, drug returns, and assists with in-house drug reconciliation;
- The position entails work under general supervision for routine tasks and with detailed instructions on new assignments.
Requirements:
- May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems;
- 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;
- Must be familiar with standard clinical operating procedures;
- Excellent verbal and written communication skills and interpersonal skills are required;
- Must be familiar with Word, PowerPoint, and Excel;
- BS/BA in a scientific-related field.