Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.

Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart's development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and dsRNA agonists.

Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.

We are looking for a Clinical Trial Associate to join our growing South San Francisco team! This position requires working on-site in our South San Francisco office.

The Clinical Trial Associate (CTA) provides administrative and clinical trial assistance to the Clinical Operations Department in the execution of Vaxart's clinical trials across multiple studies and various tasks. The CTA functions independently once familiar with the tasks of this position and in accordance with GCP guidelines, applicable regulations, and project requirements.

The CTA must have knowledge of clinical operations processes including eTMF filling, agenda drafting, furnishing meeting minutes, invoice tracking, document reconciliation, and other clinical study tracking. An understanding of clinical analytics and sample logistics is necessary. The CTA must have knowledge and experience to assist with the management of central and specialty lab vendors. A successful candidate will be given increased responsibilities to lead specific activities and will have the ability to resolve issues, take decisions, and escalate matters appropriately. The successful candidate will also collaborate effectively with team members within Clinical and cross functional areas.

Responsibilities:

• Provide general administrative support to the Clinical Operations Department.
• Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
• Support the Clinical Operations team with ongoing conduct of studies.
• Supports staff in Clinical Operations in day-to-day trial oversight including in-house and vendors outsourced clinical site activities to ensure study timelines and deliverables are met.
• Assist in the maintenance and management of eTMF by managing the receipt, completeness, and accuracy of clinical and administrative documents into Veeva Vault.
• **** Liaises with Clinical Research Associate (CRA's) regarding reconciliation activities between the Trial Master File (TMF) and Investigator Site File (ISF).
• Assists in managing assigned logistics of site start-up activities and initiation within aggressive study timelines.
• Coordinates distribution and shipment of study-related materials.
• Attends clinical project team meetings, track meeting minutes, and tracks action items to resolution.
• Sets up teleconference calls with sites and team when required and records meeting minutes.
• Effectively communicate with internal and external team members, as needed, to ensure adequate distribution of information and coordination of activities.
• Participates in cross-functional teamwork for assigned study team(s).
• Assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.

Requirements:

• Relevant work experience and High School Diploma (or equivalent), at minimum.
• 2+ years progressively responsible experience in clinical research related in the pharmaceutical industry.
• Effective communication skills (listening, oral, written).
• Sound inter-personal skills such as being flexible and adapting to changing situations.
• Organized and proficient at multi-tasking with excellent attention to detail.
• Ability to effectively use applications such as Outlook, Excel, Word, etc.
• Effective organizational and time management skills.
• Excellent judgment, decision making skills and problem-solving ability.
• Experience in eTMF filling. Veeva Vault is a plus.
• Experience managing vendors/service providers for clinical trial conduct.
• Strong understanding and demonstrated application of clinical development guidelines, applicable regulatory authority requirements and guidance (e.g., ICH-GCP, FDA guidelines, US CFRs, etc.).
• Effective clinical skills and demonstrated ability to learn and understand applicable medical/therapeutic area knowledge and medical terminology.

In accordance with California's Pay Transparency law, Vaxart's base salary range for this position is approximately $87,000 - $90,000 USD annually. The actual salary for this role will vary based on a variety of factors including education, job-related knowledge, and experience. This range does not include equity, benefits, bonuses, or other non-monetary compensation which may be included.

Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, bonus program, stock options, 401(k) with employer matching, tuition assistance, and work-life balance.

Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by.

NOTICE TO RECRUITERS AND STAFFING AGENCIES: Vaxart, Inc. has an internal recruiting department. Vaxart may supplement that internal capability from time to time with assistance from temporary staffing agencies, placement services, and professional recruiters ('Agency'). Agencies are hereby specifically directed NOT to contact Vaxart employees directly to present candidates. Vaxart's recruiting team or other authorized Vaxart personnel must present ALL candidates to hiring managers.

To protect the interests of all parties, Vaxart will not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to Vaxart, including unsolicited resumes sent to a Vaxart mailing address, fax machine or email address, directly to Vaxart employees, or to Vaxart's resume database will be considered Vaxart property. Vaxart will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Vaxart will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.

The Agency must obtain advance written approval from Vaxart's recruiting function to submit resumes, and then only in conjunction with a valid fully executed contract for service and in response to a specific job opening. Vaxart will not pay a fee to any Agency that does not have such an agreement in place.

Agency agreements will only be valid if in writing and signed by an officer of Vaxart or their designee. No other Vaxart employee is authorized to bind Vaxart to any agreement regarding the placement of candidates by Agencies. Vaxart hereby specifically rejects, and denies any liability under, any agreement purporting to be accepted based on negative consent, negotiation with a candidate, performance, or any means other than the signature of a Vaxart officer.