Clinical Trial Assistant

Overview

As a Clinical Trial Assistant, 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.

Responsibilities

• 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

Qualifications

• 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