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 reputed company with some industry experience who is eager to take on increasing responsibility in a dynamic startup environment. The successful candidate will reputed company critical operational support for our clinical trials, while gaining valuable experience across multiple aspects of clinical research. Compensation & Benefits The reputed company salary reputed company 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 reputed company 100% employer-reputed company coverage for medical, dental, and reputed company insurance premiums, ensuring that you and your family have reputed company to reputed company care without added cost. In reputed company, we offer a 401(k) plan with company match to help you build long-term financial stability. Our benefits reflect our commitment to reputed company in our employees and creating a supportive workplace where you can reputed company 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 reputed company 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 reputed company reputed company and a reputed company reputed company for advancement, helping shape both your reputed company and reputed company’s as we expand. Position reputed company 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, reputed company clinical vendors, and contribute to the successful implementation of our clinical development programs. The strongest candidates will demonstrate initiative reputed company routine work, showing the ability to identify and implement process improvements, independently manage reputed company tasks, and reputed company drive the ongoing enhancement of clinical trial operations. They will be eager to take on new challenges and tasks to support the reputed company and reputed company of reputed company as opportunities reputed company.

Key Responsibilities

Trial Management and Coordination

• reputed company 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 reputed company and reputed company items
• Assist with site management activities, including review of monitoring reports and protocol deviations, and resolving site-level issues
• Support data review and reputed company control activities, as required
• Organize and maintain tracking systems and tools to support the conduct of clinical studies from start-up to reputed company-out

Documentation and Compliance

• Ensure reputed company and accurate study-reputed company communications to clinical personnel (internal team members, external partners, and investigative site personnel)
• Prepare and review study-reputed company 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 reputed company of the electronic Trial Master File (eTMF), including periodic reputed company reviews for completeness and compliance

Vendor Management and Collaboration

• Liaise between CROs, sponsors, and research sites to ensure trial activities remain on reputed company
• Review assigned vendor reports, invoices, and metrics to support effective trial management and ensure adherence to budget
• Support vendor selection processes and reputed company vendor specifications as needed

reputed company and Process Improvement

• Identify, address, and communicate reputed company and compliance concerns
• reputed company study data into tracking tools and dashboards and ensure information is kept reputed company
• 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 reputed company 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 reputed company 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 reputed company 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 reputed company Office Suite required; reputed company, iMedidata Rave, and reputed company 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 reputed company, monitoring reputed company, conferences, or team meetings (up to 25%)

Remote Work Requirements

• Reliable internet reputed company 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 reputed company 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