Sr. Clinical Trial Assistant

About the role

We are seeking a highly motivated and detail-oriented individual to join our Clinical Department as a Senior Clinical Trial Assistant and work as part of a team to drive success.

Responsibilities

• Develop and promote a workplace culture that values diversity of thought, promote integrity and create an atmosphere that supports coaching and fosters accountability.
• Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner.
• Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
• Responsible for study start-up activities and tracking study metrics (e.g. feasibility data, ICF review, regulatory document collection and review, and Trial Master File (TMF) tracking).
• Ensure adherence to Good Clinical Practice (GCP) and regulatory guidelines throughout the trial lifecycle.
• Coordinates oversight of the study supplies at all sites, manage study logistics, including site selection, initiation, monitoring, and close-out activities.
• Track progress against project timelines, generate regular status updates, and communicate progress and issues to management.
• Track patient enrollment and recommend solutions to increase appropriate enrollment of qualified subjects.
• Assist in the development and maintenance of clinical trial documentation, including study protocols, informed consent forms, and regulatory submissions.
• Conduct site visits and liaise with clinical site staff to ensure proper study conduct and data integrity as required.
• Aid in the preparation of training materials used to train site staff during the SIV and at other times to trial-specific industry standards.
• Generate reports or notes to files, and file/collate trial documentation and reports.
• Aid in the preparation and coordination of review of study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, and Informed Consents.
• Aid in planning and participating in investigator meetings.
• Attend internal study team meetings; prepare study team agendas, responsible for taking meeting minutes and distributing study team agenda(s), meeting minutes and action items.
• Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience.
• Train and mentor entry-level staff.
• Maintain all appropriate corporate standards for facility safety and hazardous material management.

Qualifications

• BS/MS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent).
• 5+ years of experience in clinical trial administration, with a deep understanding of the clinical trial process and regulatory requirements.
• Global clinical trial experience; Familiarity with clinical trial design and methodology, including Phase I-IV trials.
• Proven experience in managing multiple clinical trials simultaneously while maintaining high attention to detail.
• Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
• Experience with clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS), including report generation.
• Excellent organizational, written and verbal communication skills; and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
• Proficiency working with Microsoft Office Suite Products.
• Ability to work across global time zones (including EU, APAC).
• Willingness to work occasional weekends based on study needs.
• Ability to travel (domestic/international), if necessary.

Essential Physical Characteristics

Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

Company Overview

ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company dedicated to transforming cutting-edge science into next-generation RNA therapeutics to treat a broad spectrum of diseases. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs.

ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.