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When it comes to life-threatening diseases, we are one family. We at Kiadis are focusing our research & development on cutting edge NK cell therapeutics, leveraging the natural strengths of our immune systems to treat serious diseases. 

 

Do you want to contribute to getting our treatments to patients worldwide?  Do you get excited from working closely together with clinical sites & vendors? And do you perform best in a dynamic fast-paced environment with ever-changing priorities? This might be the perfect role for you.

 

We are looking for a Senior Clinical Research Associate, based in the United States and can work independently in Seattle as part of a cross-functional team.

 

The role

As Senior Clinical Research Associate (Sr. CRA) you will assist in the planning and execution of clinical trials. You will work closely together with the CTM and provide assistance in vendor and site management.

In your day to day you will:

  • Support the development and preparation of standardized clinical study tools.
  • Track progress of trial activities, and may lead protocol sub-study(ies). 
  • Coordinate or lead data review and cleaning
  • Support the CTM with oversight of the clinical study while ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work instructions. 
  • Perform remote monitoring of data completed by the clinical site.
  • Travel to the site to perform source data verification and oversee site activities to ensure site is following GCP, and study protocol and procedures.

 

The ideal candidate

We are looking for someone who is experienced in supporting clinical trial operations for a fast-paced biotech company and who has an interest in infectious disease and immune-oncology and cutting edge cellular therapies. Someone who is self-driven, flexible and has a client-focused approach to work. In addition, we are looking for someone with the following qualifications :

 

  • Bachelor's degree in science or healthcare discipline required (advanced degree preferred).
  • Minimum 5 years clinical research experience [e.g. pharmaceutical, biotechnology, CRO healthcare setting (including 2 +years monitoring experience preferred)]
  • Prior work with in-house study teams in a Phase 1-3 studies, clinical support (CTA or CRA) role is highly desirable
  • Good computer skills: proficiency with MS Office Suite, PowerPoint, SharePoint and Teams in-depth knowledge of other presentation programs a plus, and the ability to learn appropriate software. Experience in electronic TMF, CTMS, and other related clinical operations systems a plus.
  • Ability to work in a self-driven capacity, with a sense of urgency and limited need for oversight
  • Client-focused approach to work; flexible attitude with respect to work assignments and new learning
  • Therapeutic expertise in Oncology with experience in hematologic oncology and Cellular or gene therapy experience preferred.
  • Knowledgeable in clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, as required
  • Solid organizational skills, interpersonal skills and communication skills (both written and oral)
  • Demonstrates problem-solving skills, self-motivated and adaptable to a dynamic environment
  • Experience in interactions with vendors preferred (e.g. CROs, central laboratories, and other vendors) and able to build effective working relationships throughout the organization internally and externally to achieve goals.
  • Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to details
  • Availability to work with colleagues and vendors in multiple time zones, including in the EU
  • Ability to travel for work and occasionally  over weekends to support Clinical Investigator and CRO study team meetings

 

What we offer

People from all over the world, together as one team, contribute to improving the lives of patients every day. We offer an exciting position in an innovative, dynamic and inspiring environment where you'll receive a competitive remuneration package, autonomy and the opportunity to make your own mark within the organization.  

 

We create an environment where ideas are shared, experiences are impactful, and talent is developed. Because of our inclusive and family-like environment, you will always have a feeling of belonging & appreciation.  

 

 

Kiadis Pharma is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. 

 

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Talent Acquisition Department. We kindly request that recruiters not contact employees/hiring managers directly to solicit business and present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Talent Acquisition Department and the recruiting agency will not create any implied obligation.  


Nearest Major Market: Seattle