Job Opportunities

Clinical Research Associate 2 (CRA-1031) 

AN2 Therapeutics, Inc. (AN2) is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. Founded by a team of experienced industry leaders in infectious diseases drug research and development, we strive to provide patients with treatments that will restore their health and enable them to live productive lives. AN2 is a mission-driven company with a passion for improving global public health and a vision to accelerate development of novel medicines to treat serious infectious diseases and save lives worldwide. We believe our company thrives when all employees share this mission.

Reporting to the Senior Director, Clinical Operations, AN2 is seeking a Clinical Research Associate who will be accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones while working independently. External relationships are with clinical investigators and other clinical research vendors as needed to support business objectives for the department and/or function.

Responsibilities:

  • COORDINATION/COMMUNICATION, ADMINISTRATION & PERSONNEL DEVELOPMENT:
    • Ensure compliance with the application and communication of all AN2 policies, procedures and fundamentals
  • FUNCTIONAL SUPPORT:
    • May participate in continuous improvement processes for functional area
  • PROJECT SUPPORT:
    • Performs ongoing reviews of vendor TMF to assure quality of the documentation files and compliance with GCP and ICH Guidelines.
    • Accountable to develop and review regulatory documentation to support study start up activities for site initiation visits (SIVs)
    • Participate in SIVs with vendor CRAs
    • Performs sponsor oversight co-monitoring visits with vendor CRAs
    • Act as primary liaison for assigned study sites to convey project information and answer questions in accordance with the Clinical Operations escalation pathway
    • Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of clinical trial documentation. May collaborate with CRO CRA and/or Lead CRA to ensure that Corrective and Preventative Action Plans (CAPAs) with investigative sites are overseen
    • Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and AN2 SOPs
    • Attends Investigator Meetings and study-specific training for assigned trials
    • Collaborates with the CRO team to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics
    • Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for patient safety and regulatory compliance for all assigned sites
    • Liaises with CRO to secure confidentiality agreements, master service agreements, clinical trial agreements as appropriate. Uses this information to prioritize sites for approval
    • Monitors recruitment remotely through CRO IRT and EDC systems and/or communication with sites
    • Prepares and reviews various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, retrieval of such documents as protocol, IB, etc.)
    • Provides quality overview and consistency check on all developed ICFs 
    • Responsible to assure adequate and appropriate dissemination of information according to the study-specific communication plans between sites, CRO and in house team to ensure project success
    • Understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across sites
  • STAFF DEVELOPMENT:
    • May provide active mentorship of Clinical Operations staff to build talent across the department
    • May provide support in the identification of training gaps, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department
    • May support the maintenance of guidelines, training programs, policies and procedures
  • TEAM COORDINATION:
    • Active membership to project teams. Contributes to CORE Team Meetings
    • Participates in cross-functional teams to assure timely attainment of project milestones
    • Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure
    • Responsible to maintain focus, locally, for specific project activities within Clinical Operations priorities
  • TRAINING:
    • Attend relevant symposia, conferences and scientific meetings, as necessary
    • May identify training needs across Clinical Operations and provide support of the creation, development and/or training to meet those needs
    • This includes any lessons learned sharing across the project team members and/or Clinical Operations
  • PHYSICAL REQUIREMENTS:
    • Approximately 20% overnight travel for meetings, site visits and/or trainings
    • Home or Office based in Menlo Park, CA

Qualifications and Experience:

  • A Bachelor s degree is required, preferably in a science-related discipline
  • A minimum of two (2) years of direct expertise of site management and logistical execution of clinical trials within a pharmaceutical, biotechnology, CRO and/or healthcare setting required
  • Must have demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
  • Must have the ability to demonstrate core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
  • Must have knowledge of GCP as relates to clinical trial management


By joining our small, highly-dedicated and motivated team, you will experience a culture that is inclusive, supportive, and humble, yet challenging. We set our egos aside to collaborate for the benefit of the team, and most importantly, the patients in need of new therapeutic options. AN2 is a company with a passion for improving global public health. We approach our business using a double bottom line strategy – with the intention of a fiscal and social return - this is reflected in our Core Values and is the foundation of our company’s culture. We employ the industry’s best to create a corporate culture that is fun, humble, respectful, and fulfilling, and where employees feel that they are making a difference and feel inspired to bring their passion to work.

We are an equal opportunity employer that values diversity, equity, and inclusion. We consider all qualified applicants regardless of race, sex, gender identity or expression, sexual orientation, age, religion, national origin, marital status, veteran status, or ability status. We will ensure that individuals who are differently abled are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment as provided to other applicants or employees. Please contact us to request accommodation.

Our open positions are managed through our Human Resources department. Unsolicited resumes from recruiting agencies, in advance of a specified agreement, will not be accepted. Resumes sent directly to our employees or our consultants from recruiting organizations will also not be accepted as referrals and do not obligate us to pay fees. 

Please send your resume to careers@AN2therapeutics.com and include the job title and CRA-1031 number in the subject.

* AN2 Therapeutics is based in Menlo Park, CA, but employees are currently working remotely due to the COVID-19 pandemic.