Sr. Clinical Trial Associate / Clinical Trial Specialist (Remote, US-based)

The Sr. Clinical Trial Associate / Clinical Trial Specialist role offers an exciting opportunity to join our fully remote clinical operations team. Reporting directly to the head of Clinical Operations, this position is ideal for an early-to-mid career professional with some industry experience who is eager to take on increasing responsibility in a dynamic startup environment. The successful candidate will provide critical operational support for our clinical trials, while gaining valuable experience across multiple aspects of clinical research. Compensation & Benefits The base salary range for this position is $70,000 – $95,000 USD per year, based on qualifications and geographic location. We are proud to offer a comprehensive benefits package along with a competitive salary. We provide 100% employer-paid coverage for medical, dental, and vision insurance premiums, ensuring that you and your family have access to quality care without added cost. In addition, we offer a 401(k) plan with company match to help you build long-term financial stability. Our benefits reflect our commitment to investing in our employees and creating a supportive workplace where you can thrive personally and professionally. Why Join Us? At our growing pharmaceutical startup, you’ll be part of a small, dedicated team developing life-changing therapies across multiple therapeutic areas. You’ll enjoy the agility and excitement of a startup while gaining valuable skills, making meaningful contributions, and collaborating remotely in an environment that values initiative and creative problem-solving. As you work directly with senior leadership on clinical development programs, you’ll have unique opportunities for professional growth and a clear path for advancement, helping shape both your future and the company’s as we expand. Position Overview As a Sr. Clinical Trial Associate / Clinical Trial Specialist you will support the day-to-day execution of one or more clinical trials, ensuring compliance with established SOPs, GCP, and applicable regulatory requirements. You will work closely with the Pasithea clinical development team and CRO to manage trial documentation, coordinate with research sites, oversee clinical vendors, and contribute to the successful implementation of our clinical development programs. The strongest candidates will demonstrate initiative beyond routine work, showing the ability to identify and implement process improvements, independently manage complex tasks, and actively drive the ongoing enhancement of clinical trial operations. They will be eager to take on new challenges and tasks to support the success and growth of the company as opportunities arise. Key Responsibilities Trial Management and Coordination • Provide operational support for the planning, execution, and closeout phases of clinical trials • Participate in study team meetings, assist with preparation of materials and agendas, and maintain accurate records of decisions and action items • Assist with site management activities, including review of monitoring reports and protocol deviations, and resolving site-level issues • Support data review and quality control activities, as required • Organize and maintain tracking systems and tools to support the conduct of clinical studies from start-up to close-out Documentation and Compliance • Ensure timely and accurate study-related communications to clinical personnel (internal team members, external partners, and investigative site personnel) • Prepare and review study-related documents and reports in accordance with GCP/ICH regulatory requirements and study protocols • Create and disseminate study materials, including newsletters, templates, and manuals under the direction of senior team members • Contribute to the maintenance and oversight of the electronic Trial Master File (eTMF), including periodic quality reviews for completeness and compliance Vendor Management and Collaboration • Liaise between CROs, sponsors, and research sites to ensure trial activities remain on track • Review assigned vendor reports, invoices, and metrics to support effective trial management and ensure adherence to budget • Support vendor selection processes and develop vendor specifications as needed Quality and Process Improvement • Identify, address, and communicate quality and compliance concerns • Enter study data into tracking tools and dashboards and ensure information is kept current • Contribute to clinical operations initiatives including creation and updating of standardized clinical trial tools and procedures • Participate in process improvement activities to enhance operational efficiency Qualifications Education and Experience Required: • Bachelor's degree in life sciences, clinical research, or related field, OR equivalent combination of relevant industry experience and training. (Candidates without a bachelor’s degree may be considered if they demonstrate significant clinical trial experience, knowledge of ICH-GCP, and proven capability in the required responsibilities.) • 2-5 years of experience in clinical research or clinical operations • Strong understanding of clinical trial regulations, GCP guidelines, and clinical research processes • Previous experience in a pharmaceutical, biotechnology, or CRO setting Preferred: • On-site clinical monitoring experience • Experience in oncology, neurology, and/or rare disease therapeutic areas • Relevant professional certification (e.g., CCRP, CCRC, or similar) • Previous experience as a clinical research coordinator, or similar role Skills and Attributes • Ability to work both independently and collaboratively in a fast-paced environment, and absorb new information rapidly • Excellent organizational and time-management skills with strong attention to detail • Proactive problem-solving abilities and analytical thinking • Effective written and verbal communication skills • Proficiency with Microsoft Office Suite required; Veeva, iMedidata Rave, and Smartsheet preferred • Adaptability and willingness to take on multiple responsibilities in a startup environment, own them, and reliably deliver • Ability to travel domestically and internationally for site visits, monitoring oversight, conferences, or team meetings (up to 25%) Remote Work Requirements • Reliable internet connection capable of supporting video meetings and secure data transfer. • A private workspace free from distractions to ensure confidentiality and productivity. • Ability to maintain compliance with company IT and data security policies while working remotely. • Willingness to be available for virtual meetings and collaborate across multiple time zones, as needed. Please note: Candidates must ensure that their remote work environment meets these requirements prior to their start date. A company laptop will be provided. Apply tot his job Apply To this Job