Position Type: Regular

Position Title: Principal Clinical Research Associate

Location: East Bay, CA

Position Number: 702

Position Description:

Regular position with global biotech company in San Francisco east bay. Highly regarded organization to work in; values performers and cultivates open communications that allow for differing and challenging opinions. Strong work-life balance ethic. Career support and training orientated organization.

 

Role is to lead the implementation of clinical research plans and independently coordinates/execute clinical research activities for multiple studies or complex single studies.

Other activities;

  • Support the evaluation and registration of products
  • Offer technical input to study designs, clinical development plans and protocols
  • Manage assigned studies through all phases of study process and work with budget and timelines
  • Plan, forecast and manage study logistics and develop study operation documents and data collection forms (CRFs)
  • Identify, qualify, train and manage study sites as well as conduct and document study per protocol, Good Clinical Practices (GCP) guidelines and SOPs
  • Serve as first line technical expert on assay and systems and troubleshoot/document instrument problems on assigned projects
  • Train and mentor junior staff in GCP and project coordination skills.
  • Represent department on project teams and Life Cycle Teams
  • Represent company at study sites and symposia.

Educational and Other Requirements:

  • Bachelor's or Masters in Biology, Chemistry, Molecular Biology or related discipline.
  • 8-10 years of CRA experience or at least 6 years as a CRA and the last 2 years as a Lead CRA. 
  • Extremely detail oriented, self starter
  • Excellent lab skills, especially in the area of microbiology/virology and/or molecular testing
  • Clinical Laboratory Scientist experience very desirable
  • Ability to work in a team situation
  • Ability to solve problems in a detailed, comprehensive manner with demonstrated urgency and energy to handle problems
  • Must meet timelines and manage sites
  • Excellent written and verbal communication skills and good presentation skills are required.
  • MS Word, Excel and PowerPoint skills are required
  • Up to 35% travel may be needed (domestic and international)

 

Salary Range: Competitive

Contact: Contact Us