The Clinical Trial Associate (CTA)/Sr CTA is responsible for supporting the management of clinical trials, including close contact with study vendor team members. This position will report to the Clinical Project Manager and work cross functionally to assist the clinical development team with ensuring that all Nocion clinical programs are conducted in accordance with ICH GCP (e.g. E6(R2)) and all local regulations in countries where clinical conduct takes place. Strong candidates will bring experience and knowledge in the fundamental aspects of trial and study site management, vendor relations, and experience in the full cycle of study from start to completion (start-up through close out).
This is a unique opportunity to join a small, nimble biotech outfit that is working tirelessly to bring a pipeline of clinical candidates into the clinic in an efficient, safe manner with the ultimate goal of improving the lives of patients!
Specifically, the CTA/Sr CTA:
• Assists in all aspects of clinical study site identification and activation
• Assists the Clinical Project Manager (CPM) with all aspects of trial start-up, including review of study plans, protocols, lab/pharmacy manuals, electronic case report form and database generation, interactive web response system creation, etc.
• Helps to create and maintain study-specific start-up trackers, tools, and documents
• Attends internal and external team meetings/teleconferences
• Work closely with the CPM, VP of Clinical Development, and Chief Medical Officer (CMO) to create (and present, when applicable) formal presentations of relevant trial information to various stakeholders throughout the course of the clinical trial
• Assists in informed consent form (ICF) development and management, both central and local ICFs
• Performs thorough quality review of essential regulatory packages from clinical trial sites
• Ensures required study documents are submitted to the electronic trial master file (eTMF) or electronic document management repository (EDMS); assists the CPM with periodic audit of the eTMF
• Works directly with clinical trial site staff, when necessary, to provide support on protocol-related questions and oversight of research conduct at trial sites
• Works closely with the CPM, VP of Clinical Development, and CMO to develop tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points
• Works with the CPM to develop strategy and execution of oversight of clinical monitoring being conducted by the CRO
• Assists in the customization of clinical site contracts & budgets, where necessary
• May participate in training CRO teams and in the onboarding of new CRO team members
• Must be willing to travel 10-15% of the time, during certain periods of trial conduct. Currently, all work-related travel is on hold. Travel will only be required once travel activities can safely resume.
Qualifications & Requirements
• BS/BA in science or health discipline
• Ideally, a minimum of 1 (CTA role) – 3 (Sr CTA role) years clinical research experience either at a clinical or academic research organization, clinical trial site, or at a biotech or pharmaceutical company
o NOTE: Applicants with 0 – <1 year of experience will also be considered
• Basic understanding of clinical drug trials and willingness to learn quickly on-the-job
• Excellent verbal and written communication skills
• Ability to work under aggressive timelines
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Independently motivated to learn and lead
• Proficient in MS Office (Excel, PowerPoint and Word)