Clinical Trial Assistant

Role Summary

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.
• Prepare, handle, disseminate, and file clinical documentation and reports, as well as study-related correspondence, including the generation of meeting minutes and agendas.
• Assist with the creation, maintenance, and tracking of clinical trial documentation, including the Trial Master File (TMF).
• Create and maintain study-related tracking in Smartsheet.
• Compile, format, and publish large clinical documents associated with clinical trials.
• Coordinate central IRB submissions under supervision.
• Complete ClinicalTrials.gov study-related submissions and updates in coordination with Clinical Trial Manager, per regulatory requirements.
• 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 drug receipt.
• Provide support for regionally-based monitoring team to ensure efficient site activation, training, and oversight, maintaining compliance with study protocols, regulatory standards, and international clinical research guidelines.
• Create and manage internal and external communications, including presentations
• Assist with maintaining and updating project-related data in databases, i.e., Clinical Trial Management Systems.
• Review clinical documents (study plans, ICFs, monitoring visit reports, etc.) for accuracy and sufficiency, as needed by Clinical Trial Manager.
• Assist team to ensure documents are maintained in audit-ready condition.
• Collaborate with key stakeholders (internal and external) and vendors in the development and ongoing management of clinical trials and research projects.
• Arrange teleconferences, meetings, and events.
• Ensure compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements
• Other tasks as needed

Qualifications

• Minimum High School Degree/GED required with 5 years of relevant industry experience; College degree preferred
• 2 years of experience in the pharmaceutical, biotechnology or CRO industry with demonstrated expertise in relevant clinical operations activities with clinical trials Phases 1-4
• Experience with electronic trial master file systems preferred.
• Strong knowledge of Microsoft systems, including Word, Excel, and Adobe Acrobat.
• Strong technical aptitude and knowledge of Smartsheet preferred.
• Strong written and interpersonal communication skills and strong attention to detail.
• 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, including the ability to format and publish large documents and create tracking systems and spreadsheets.
• Aptitude to learn additional software programs and databases.
• Ability to handle multiple tasks simultaneously; manage and prioritize workload in a proactive manner; and demonstrate effective time management skills.
• Strong organizational, communication, and interpersonal skills.
• High degree of professionalism.
• Ability to work in a hybrid environment with related onsite expectations in New Haven, CT a minimum of 3 days a week (Tuesday-Thursday)