Job Description:
We are seeking a highly motivated and detail orientated individual to join our Clinical Department as a Sr. Clinical Trial Assistant and work as part of a team to drive success. The Sr. CTA will support all phases of clinical study activities under the direction and supervisor of the ADARx Clinical Operations Lead(s). The CTA will monitor and resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), Code of Federal Regulations (CFRs), International Conference of Harmonisation – Good Clinical Practice (ICH-GCP), and specific country regulations; ensuring study is conducted within clinical trial protocols.
Essential 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.
- Assist with preparing 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.
- Assists with filing and archiving project documentation in internal document system and the eTMF within the defined timelines as well as QC reviews of CRO filings and needed follow-up
- Assist with preparing and coordinating review of study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, and Informed Consents.
- Assist with planning and participating in investigator meetings.
- Attends internal study team meetings; prepares study team agendas, responsible for taking meeting minutes and distributes study team agenda(s), meeting minutes and action items
- Reviews and recommend updates for departmental SOPs, may draft updates to SOPs depending on experience and level.
- 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.
- Other duties as assigned.
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.
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.
Required Key Attributes:
- Must be able to work independently with supervision as needed.
- Proficient at working independently as well as in cross-functional team settings
- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
- Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.
- Strong problem-solving skills and a proactive attitude towards exploring new approaches.
- Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
Work Authorization:
- United States (Required)
- Background Check
- As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.
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.
