Research Associate, Clinical Development & Operations

 

Evolve BioSystems, Inc. – Davis, CA

Reporting to the Director of Clinical Development & Operations, the Research Associate, Clinical Development & Operations will be responsible for contributing to the execution of multiple clinical trials from study start-up to final data reporting. This person will collaborate with leadership and the cross functional team to design and oversee clinical trials that support commercialization strategies, regulatory requirements, and product development. This person thrives in a team environment and is willing to contribute whenever a need arises. Strong attention to detail is a must for this position!

Key Responsibilities:

  • Review and compile scientific literature to support clinical programs
  • Generate and proof clinical trial documents with extreme attention to detail – protocols, informed consent forms, CRFs, study reports, plans, SOPs
  • Coordinate site selection – feasibility questionnaires, investigator evaluations
  • Prepare central IRB submissions
  • Train study site personnel
  • Monitor study data
  • Coordinate production of clinical trial materials with Supply Chain team
  • Coordinate study specimen collection, including tracking and logistics
  • Analyze data and draft manuscripts and reports
  • Support regulatory and IP research and document generation

Knowledge, Skills and Abilities:

  • Passion for Evolve’s mission
  • Strong scientific background, with ability to comprehend scientific literature and laboratory analyses for microbiome-based research
  • Comfortable working as part of a team to accomplish corporate goals
  • Execution-oriented with the ability to achieve accuracy and thoroughness
  • Ability to thrive in an entrepreneurial, fast paced, and dynamic environment
  • Ability to multi-task and prioritize objectives
  • Strong interpersonal, communication, and influencing skills
  • Comfortable sharing scientific information
  • Professionalism with physicians and other medical professionals
  • Excellent writing skills for clinical trial, regulatory, and IP document generation
  • Basic data analytical skills

  • Strong technical aptitude with web-based tools and electronic data capture systems, and intermediate to advanced proficiency of the Microsoft Office Suite

  • Willingness to travel domestic and international (when required) up to 20%

Experience/Education:

  • BA/BS or RN degree required

  • Minimum 3-5 years Clinical Trials experience in industry (pharma/biotech/CRO)

  • Thorough understanding of GCP guidelines for the conduct of human clinical trials

  • Experience in clinical trials of probiotics or biologics is a plus!

  • Experience in clinical trials with babies or pregnant women is a plus!


Interested in this position? Please email your resume to: rflannery@evolvebiosystems.com