As a Clinical Trial Associate, you will have the opportunity to work with a well-established and collaborative Clinical Operations team. This role will contribute to the implementation and management of Clinical Trials through supporting the Clinical Trial Managers and Clinical Operations leadership. 

• Supervise the receipt and dissemination of study related documents and correspondence from clinical sites; screen documents for completeness and compliance in accordance with trial manager instructions; investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of data.
• Assist in creation and maintenance of electronic Trial Master File. File clinical documents. 
• Assist with preparation of study-related correspondence, including the generation of meeting minutes and agendas.
• May set up and maintain study related tracking in Smartsheet
• Coordination of central IRB (Institutional Review Board) submissions
• Under supervision, communicate with sites and vendors to provide information, track documentation and overall progress of clinical trials and adherence to established guidelines; ensure that study materials and drug kits are shipped and resupplied as requested; document all conversations.
• Responsible for producing meeting minutes from internal team meetings.
• Provide support for regionally based monitoring team
• Create presentations and correspondence. 
• Assist with maintaining and updating project-related data in a database, i.e., CTMS, etc.
• Liaise with internal and external contacts worldwide. Arrange teleconferences, meetings and events. 
• Compile, format and publish large clinical documents associated with clinical trials.

• Ensure that all activities and interactions are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Celldex values

• Minimum High School Degree/GED Required with relevant 5 years of relevant industry experience, College degree preferred
• 2years of experience in the pharmaceutical, biotechnology or CRO industry for CTA, 2-3 years of experience for Senior CTA
• Strong knowledge of MS Word, and Excel.
• Strong technical aptitude
• Knowledge of Smartsheet, preferred
• Strong written and interpersonal communication skills and strong attention to detail
• The ability to work independently and as part of a team.
• Must have demonstrated expertise in relevant clinical operations activities
• Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
• Working knowledge of FDA regulations and ICH/GCP guidelines.
• Strong Computer Skills (MS Office) including the ability to format and publish large documents and create tracking systems and spreadsheets.
• Aptitude to learn additional software programs and databases.
• High degree of professionalism.
• Ability to handle multiple tasks simultaneously; manage and prioritize workload in a proactive manner.
• Experience with electronic trial master file, preferred 

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach