Careers

Immunexpress is a privately held company developing molecular diagnostic tools to aid clinicians in improving outcomes for suspected sepsis patients. Sepsis affects more than 1.6 million patients in the US every year and is the most expensive complication contributing to patient costs in US hospitals, totaling over $20 billion each year. Sepsis is difficult to diagnose, and there is an overwhelming clinical need for better diagnostic tools.

Immunexpress’s dynamic and innovative environment offers our employees the opportunity to advance and commercialize diagnostic tools to aid in differentiating infection from non-infectious causes of systemic inflammation, as well as early identification of the type of infection, in suspected sepsis patients.

Note: Immunexpress provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, we comply with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

We are expanding our operations and welcome dedicated and talented applicants to apply to join our growing team.

Please send resumes to [email protected]; include a cover letter that highlights your qualifications and matches our requirements. Immunexpress offers competitive salaries and an excellent benefits package to its employees.

Clinical Research Associate
Seattle, WA, USA

Title

Clinical Research Associate

Purpose

  • To monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
  • To assist in the management of the day to day operations of clinical trials.

Key Internal Relationships

Reports to:
Director, Clinical Operations (Direct)
Chief Medical Officer (Functional)

Qualifications

  • Bachelor’s degree in relevant scientific disciplines.
  • Must have a minimum of 2 years of related clinical research experience.
  • Alternatively, an equivalent combination of education, training and experience.
  • On-site monitoring experience preferred.
  • Certified Clinical Research Associate (CCRA) certification (highly desirable).

Experience, Understanding Of & Ability In

  • Provides significant hands-on support for clinical trial activities.
  • Monitors clinical sites and provides technical assistance, as necessary.
  • Participates in development of protocols, case report forms (CRF), clinical trial procedures, study documents, and training materials.
  • Assist in the management of the Trial Master File.
  • Demonstrates working knowledge of FDA regulations, ICH/GCP and other regulatory requirements.
  • Ensures site compliance with regulations and study protocol.
  • Evaluates the quality and integrity of site practices – escalating quality issues as appropriate.
  • Performs site selection, initiation, monitoring and close-out visits and maintains appropriate documentation.
  • Manages progress by tracking recruitment, CRF completion, and data query resolution.
  • Creates and oversees corrective action plans for the clinical sites.
  • Willingness and capability of traveling within North America for as much as 40-50% of time or as required by specific study/project needs.
  • Proficiency with Microsoft Office Suite, electronic data systems, and other database programs is required.
  • Must possess excellent interpersonal skills. Must have the ability to build and maintain positive relationships with management, colleagues, and study teams.
  • Must have the ability to work independently and maintain confidentiality.
  • Excellent oral and written communication skills. Must display strong analytical and problem solving skills.
  • Attention to detail and accuracy are essential.
  • Comfort in small company. Understands the start-up environment.

Position Scope & Accountability

  • This role requires close interaction with Director Clinical Operations, Director Regulatory & Quality, Director Bioinformatics, and Chief Medical Officer.
  • The role will require knowledge of functional areas of initiating, planning, executing, controlling, closing and resourcing clinical trial projects.
  • The role requires close attention to details, but also a high level of interpersonal skills for internal and external communications to realize deliverables.
  • The role requires management of, and participation in, multiple concurrent fields of expertise – product development, regulatory and quality, and clinical affairs.
  • The role will require some traveling to perform site visits and monitoring activities.

Desirable Traits & Skills

  • A team player who is eager to identify and solve problems, and who will promote cooperation in all functional areas.
  • Excellent written and verbal communication, including listening skills, with an ability to distill information, and create order, structure and plans with and for a range of key stakeholders.
  • Ability to motivate people, while at the same time, driving performance to strict timelines and budgets in an aggressive young company.
  • Attention to detail, as well as the ability to see the ‘big picture’ and the role of the project within the company’s strategic direction.
  • Able to work in an environment where sharing responsibility for success and failure is critical to overall success.