Clinical Trial Assistant

Overview

Responsible for performing multiple tasks that support clinical trials, with duties that include assisting Clinical Operations staff with activities related to clinical trials, creating and maintaining documents and tracking systems, maintaining accurate files and filing systems, etc.

Responsibilities

• Assist the clinical operations team to initiate, conduct, and complete Phase 1 - 4 clinical trial activities. Provide accurate and up-to-date site information to operations team and cross-functional collaborators as needed.
• Develop and implement accurate tracking systems, forms, and other relevant documents to support clinical trial studies.
• Develop and maintain nonclinical supply materials such as study support documents and reference manuals (study reference and pharmacy manuals, initial site regulatory binder).
• Order nonclinical supply materials, and generate and maintain tracking of these materials.
• Request and track investigator payments, as needed. Work with Clinical Operations and Finance to resolve payment issues.
• Assist in creation of studies within the system per SOPs, track study-specific data, and generate reports.
• Assist in the distribution of key clinical trial documents (i.e., investigator brochures, protocols, informed consents, regulatory submissions).
• Receive and review regulatory documents from clinical sites.
• Maintain effective tracking systems and communication with internal and external customers to ensure updates of appropriate regulatory documents (i.e., 1572s, financial disclosures).
• Coordinate documentation for clinical study supply releases with investigator sites and ensure that Regulatory is provided with appropriate documentation of approved investigator sites that will allow centers to be opened, e.g., IRB/EC approvals.
• Submit and track essential documents to the trial master file (TMF) on an ongoing basis, and perform periodic review of TMF and clinical development documents throughout the project life for completeness and accuracy.
• Maintain files of clinical trial documents for ongoing projects and assist in the archival of CRO study files and legacy documentation.
• Coordinate logistics for study meetings, medical expert meetings, investigator meetings, kick-off meetings, etc. Prepare draft minutes from the various meetings for review and finalization by the study team.
• Assemble documents and supplies as needed to support monitoring visits.
• Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.
• Other duties as assigned.

Qualifications

• BS degree in life science or nursing with 1 - 2 years' experience as a clinical trial assistant or study coordinator. Or, an associate degree or equivalent with 4 years of clinical trial experience, specifically working with regulatory documents or tracking documents or as a clinical trial assistant.
• Knowledge of ICH GCPs and other applicable regulatory requirements.
• Excellent interpersonal and organizational skills, as well as the ability to effectively prioritize tasks.
• Strong problem-solving skills and ability to work independently as well as work collaboratively in a team-oriented environment.
• Able to make effective use of the resources at hand.
• Effective oral and written communication skills. Must be able to communicate effectively with members of other departments and with study-site personnel (physicians, study coordinators, nurses, etc.) as needed.
• Proficient with computer applications such as Word, Excel, and PowerPoint and able to learn other applications with appropriate training.

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