We are seeking a highly motivated individual to join our team as a Clinical Trial Associate (CTA) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate operational efficiencies in clinical trials, guided by SOPs and ICH-GCP.
Prior to joining, your experience will have been from a clinical research organization, hospital or large medical specialty clinic, or work at another biopharma. You will be familiar with clinical data and clinical trial terminology, be able to read standard medical abbreviations that are used in the world of medical practice and clinical studies. You will have familiarity with FDA regulations, GCP, essential study documents, and key study activities such as; tracking patient screening and enrollment, clinical laboratory sample collection, regulatory documents, and study team communications. Problem solving skills will be used daily. And did we mention - being highly organized is essential.
Essential Duties and Responsibilities:
• Assist with the setup, maintenance and oversight of the Trial Master Files (TMF), including TMF plan.
• Support the cross-functional team with the circulation of documents for cross functional review, filing of documents in study working folders, and collation and QC of documents for the TMF submission.
• Assist the clinical project manager/lead and study team with the drafting of meeting agendas, meeting minutes, and managing meeting logistics (meeting room, calendar invites).
• Assist in the planning and preparation for internal/external meetings (e.g. CRO Face-to-face meetings, investigator meetings, conferences).
• Ensure the completeness and accuracy of essential regulatory documents for study drug shipment.
• Assist the Clinical Operations team with preparing and reviewing documentation (e.g. study manuals and plans) for assigned trials.
• Access study systems e.g. clinical database, eTMF, CTMS, etc. to support study oversight activities
• Assist with the tracking and oversight of laboratory sample collection, processing and shipping information.
• Assist the study team with the update and maintenance of study status trackers and status reports.
• Develop and maintain study team roster and vendor contact lists.
• Assists with the development of study materials, e.g. study newsletters, study templates etc., as needed.
• Source and distribute study supplies, as needed.
• Maintain study tracking tools and study calendars.
• Assist with tracking invoices and obtaining internal approvals for payments; work with CPM to verify accuracy of information prior to approval.
• Assist with the creation and circulation of Purchase Orders for approval,
• Assist the study team with preparing study updates for internal and external stakeholders.
• Balance competing and evolving priorities across trials.
• Collaborate closely with internal and external stakeholders to support the execution of clinical studies.
• Other duties as assigned
Desired Skills & Experience:
• BS / MS or equivalent
• 2-3 years’ experience in clinical research at a hospital, CRO, or biopharmaceutical company is desirable
• Superior understanding of Microsoft Office
• Aptitude for organizational detail
• Capacity to complete tasks independently in a highly regulated environment
• Flexibility to function well within a team environment and within condensed timelines
• Excellent written and verbal communication skills
• Strong interpersonal skills
• Basic understanding of learn FDA regulatory requirements and good clinical practice (GCP)