The Clinical Trial Associate is an opportunity for a highly motivated, organized, and proactive individual to participate in the planning and coordination of clinical trials. This role will provide project support for the Clinical Trial Manager (CTM) in the initiation, execution and close out of domestic and international clinical studies.
Clinical Trial Management
· Support the Operations team in the successful execution of assigned clinical trials from protocol concept to clinical trial report, complying with international Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs)
· Coordinate the preparation, collection and execution of confidential disclosure agreements (CDA)
· Set-up, update and maintain clinical trial-related trackers such as regulatory documents, trial master file, startup progress, screening/enrollment, study invoices/payments, project budgets and others as necessary
· Prepare, maintain, and archive trial master files
· Perform trials master file reviews to ensure completeness and audit-readiness
· Request, manage, distribute and track study supplies (Regulatory Binders, Study Reference Manuals & ancillary supplies)
· Distribute recruitment and other research subject-facing trial materials
· Assist with reviews for protocol, informed consent form (ICF), case report form (CRF) design, etc.
· Support audit/inspection readiness
· Assist study sites with IRB/EC submissions and annual reports
· Assist with compiling regulatory submissions
· Coordinate, provide set up, and attend project meetings including: internal team, CRO / vendor meetings, support presentations, etc.
· Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides) as applicable
· Assist with identifying and implementing best practices and continuous improvement plans within the company
Cross functional Mentoring and Leadership
· Work cross-functionally to ensure clinical program timelines and goals are met.
· Provide study-specific mentoring and/or line management for junior team members, as appropriate.
· Participate in operational improvement initiatives (e.g. SOP development, training, etc.)
· Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports
Fiscal and Contracts Management
· Review site budgets, collaborate with finance to provide input into financial reporting and projections.
· Assists in creation of scope of work, budgets, vendor performance and issue resolution.
· Reconcile and report vendor and site payments, approve invoices and change orders ensuring accuracy and timely delivery to finance.
· Highly motivated and proactive self-starter, able to organize and perform complex tasks with minimal supervision.
· Strong team participation and leadership skills, including excellent interpersonal and communication skills.
· Strong written and verbal communication skills.
· Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative influence and negotiation skills.
· Ability to seek guidance when required and inform manager of situations as they arise.
· Strong computer skills including knowledge of Excel, Word, PowerPoint, MS Project and Outlook.
Education & Experience Requirements
· 1-2 years of experience in clinical research at a Pharmaceutical, Biotech or Medical Device organization, or equivalent site experience
· Basic knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements
· Experience with managing one or more Trial Master Files (TMF)
· Experience working in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Safety, Product Development, Finance)
· Experience with EDC systems
· Proficient in Microsoft Office (e.g., Word, Excel, and Outlook) and web-based systems.
· Internal: Clinical Development, Data Management, Statistics, Regulatory Affairs, QA, CMC/TOX, Supply Chain, Pharmacovigilance, Medical Writing, Study Physicians
· External: Vendors, CRO’s, clinical research consultants, clinical research site staff
Other Job Requirements
· Some Travel Required (~10%)