Pc Refresh Technician

Microsoft Outlook Trial Master File Medical Guideline Case Report Forms Biopharmaceuticals Quality Management Process Improvement Document Management Microsoft PowerPoint Willingness To Learn Regulatory Compliance Clinical Documentation Taking Meeting Minutes Administrative Support Continuous Development Artificial Intelligence Regulatory Requirements Administrative Functions Pre-Clinical Development, The Clinical Trial Associate (CTA) supports the Director of Clinical Operations and Clinical Study Managers in trial start-up, execution, and close-out activities while maintaining high-quality standards and strict compliance with SOPs, policies, and regulatory requirements. This role plays a key part in the successful delivery of clinical studies by providing administrative, operational, and documentation support across the clinical development lifecycle, with a strong focus on rare disease programs. Responsibilities

• Execute delegated responsibilities across trial start-up, conduct, and close-out in alignment with expected quality standards and timelines.
• Provide comprehensive administrative support to the Clinical Operations Department and Clinical Study Managers, including coordination of study activities and logistics.
• Generate, distribute, and maintain study-related agendas and meeting minutes to ensure clear documentation and follow-up of action items.
• Maintain and update study tracking tools and logs to ensure accurate and current information on trial status and key metrics.
• Coordinate and manage correspondence with Institutional Review Boards (IRBs) as needed to support submissions, approvals, and ongoing reporting.
• Assist Clinical Study Managers with oversight of CROs and vendors by supporting tracking, communication, and documentation of performance and deliverables.
• Support review and quality control of study-specific documentation, including clinical protocols, informed consent forms (ICF), study plans, study reference manuals, and case report forms (CRFs).
• Collaborate with Document Management to implement and maintain Trial Master File (TMF) specifications in alignment with program milestones and regulatory expectations.
• Assist with document filing, organization, and maintenance in the electronic Trial Master File (eTMF), ensuring completeness, accuracy, and inspection readiness.
• Perform quality reviews of TMF and eTMF content to ensure compliance with SOPs, ICH-GCP, Good Documentation Practices (GDP), and regulatory requirements.
• Support inspection readiness activities by ensuring documentation is complete, well organized, and easily retrievable for audits and regulatory inspections.
• Contribute to activities supporting Biologics License Application (BLA) submissions through accurate documentation management and data support.
• Support site management activities, including tracking site documentation, communication, and status updates.
• Assist with data review activities to ensure data quality, consistency, and alignment with study protocols.
• Collaborate with cross-functional stakeholders in a fast-paced environment and proactively identify and resolve documentation or process issues.
• Demonstrate a continuous learning mindset and contribute to process improvements within Clinical Operations and Document Management., Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. Related Jobs Buyer Aston Carter

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Filing Auditing Visionary Operations Management Innovation Coordinating Data Quality Communication Life Sciences Pharmaceuticals Detail Oriented Microsoft Excel Clinical Trials Time Management Quality Control Microsoft Office Drug Development, Ability To Meet Deadlines Engineering Design Process Verbal Communication Skills Good Documentation Practices Electronic Trial Master File Good Clinical Practices (GCP) Institutional Review Board (IRB), * Minimum of 3 years of experience as a Sponsor Clinical Trial Associate (CTA), preferably with a small sponsor environment.

• Minimum of 3 years of experience in pharmaceutical drug development and clinical operations.
• Sponsor-side clinical operations experience, with a focus on supporting clinical trials from start-up through close-out.
• Hands-on experience with Trial Master File (TMF) and electronic TMF (eTMF) systems, including implementation and maintenance of TMF specifications.
• Proficiency with Veeva or similar eTMF/clinical documentation platforms.
• Strong administrative skills and experience supporting clinical documentation and study logistics.
• Working knowledge of the drug development process and clinical trial lifecycle.
• In-depth knowledge of International Council for Harmonisation - Good Clinical Practice (ICH-GCP) guidelines.
• Strong understanding of Good Documentation Practices (GDP).
• Knowledge of and adherence to SOPs and compliance with FDA Code of Federal Regulations.
• Experience supporting inspection readiness activities for clinical trials.
• Experience supporting BLA submission-related documentation and activities.
• Experience with site management activities within clinical studies.
• Experience with data review in a clinical trial setting.
• Proficiency with Microsoft Office applications (such as Word, Excel, PowerPoint, and Outlook) for documentation, tracking, and communication.
• Ability to operate effectively in a fast-paced working environment.
• Strong attention to detail and quality focus in documentation and tracking.
• Excellent organizational and time management skills.
• Strong written and verbal communication skills to support internal and external correspondence.
• Demonstrated eagerness to learn and grow within clinical operations., * Bachelor’s degree (minimum) in a relevant field such as life sciences, healthcare, or a related discipline.
• Experience working on rare disease clinical programs, particularly those involving complex or specialized patient populations.
• Familiarity with regulatory interactions and documentation requirements for rare disease programs.
• Experience working with IRBs and understanding IRB submission and approval processes.
• Exposure to or involvement in programs progressing toward BLA submission.
• Ability to collaborate effectively with cross-functional teams including Clinical Operations, Document Management, and external partners.
• Comfort working in an evolving environment where processes may be refined and improved over time.
• Demonstrated initiative in identifying opportunities to enhance documentation quality, organization, and compliance.

Work Environment

This role operates in a hybrid work environment with an expectation of being on-site one day per week in an office setting in Pennsylvania, with the option to be on-site more frequently if needed. The position supports clinical development programs in rare diseases and involves regular collaboration with Clinical Operations, Document Management, and external partners such as CROs and vendors. Work is primarily computer-based, utilizing systems such as electronic Trial Master File (eTMF) platforms, including Veeva, and standard Microsoft Office tools. The environment is fast-paced and deadline-driven, with a strong emphasis on quality, regulatory compliance, and inspection readiness. Standard professional office attire is expected during on-site days. Job Type & Location, Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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