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Clinical Research Associate

3 months ago

Princeton, United States Planet Pharma Full time

Candidates must be local to either Santa Clara, CA or Princeton, NJ (Position is NOT remote). Candidate will be onsite at clinical sites and will be required to travel within United states 50% of the time. When not traveling to sites, these CRA's will sit in-office 4 days per week.


This is a 1-year W2 contract with longer-term potential based on performance and business. Benefits (medical, dental, vision, 401k match) are available through Planet Pharma.



Our client, a leading Diagnostic Device company, has a large amount of clinical study work needed to support regulatory submissions for both new cartridge product launches and our currently on-market cartridges.


These studies are external IVD based performance studies (mainly US sites) and are being carried out with our 2 platforms. We need to hire CRA resources to support the many products and the tight timelines. The CRA resources will help us with all of the steps and tasks required to design, prepare for, execute, monitor and close IVD clinical studies.


It is of significant benefit to identify CRA's who have worn multiple clinical study hats (i.e., not just a data monitor as this is only one element) and are able to communicate well, pivot quickly and lead various IVD clinical study tasks from a sponsor point of view (CRO experience is okay, but the candidates should be prepared to adapt to a different structure).


To collect and submit objective evidence of the performance of our products, CRAs need to:

  • lead small groups, interact well with teams yet also be independent contributors
  • depending on experience, be able to help new CRAs onboard/train
  • have good communication skills (oral/written/presentations) and be able to deal with conflicts and resolution (especially when representing the company externally)
  • be able to take responsibility for a number of studies/sites and provide updates to Management (depending on their level of experience)
  • understand i-STAT IVD products (cartridges/samples/analyzers)
  • understand preanalytical sample handling issues and be able to run various cartridges then train others and answer questions (be comfortable with this in-person/remotely)
  • support the creation of the protocol and all of the associated study documentation (brochures, ICFs, CRFs, IRB submission pkgs etc); important for training and trouble-shooting with sites
  • identify and prequalify/approve sites where the studies will be carried out
  • support the creation of study specific electronic data collection fields and system elements (additionally be able to do user acceptance testing)
  • support the creation of the clinical trial master file folders and system elements
  • work with sites to ensure all of the documentation from sites is collected prior to starting the study and is also filed
  • support preparation and execution for study site initiations, collecting documents, generating training modules etc
  • understand and be able to carry out data/site monitoring both remotely and onsite
  • support data verification and reviews to prepare collected data for analyses
  • lead and work with sites for close out of the studies
  • lead and carry out post study tasks regarding reports, trial master file documents, financial documentation etc
  • be very organized and comfortable carrying out clinical study tasks remotely and on-site (travel, US)


Required Years Experience: Typically requires 5+ years of relevant work experience or exposure to a technical / clinical environment, laboratory instrumentation and / or medical diagnostic testing to sufficiently demonstrate and fulfill the core job responsibilities of the position.


Skills: Knowledge of lab practices or point of care testing environments, regulations and standards affecting medical diagnostics, lab practices, familiarity with statistics and statistical software (desired).


Education: Bachelor's degree or equivalent experience required; prefer background in the sciences or a medically-related area (such as but not limited to Biology, Chemistry, Nursing, Medical Technology, Respiratory Therapy or related field of study).


Duties: Responsible for implementing the strategic initiatives established by the business and the department. Responsible for tactical components of creating and driving customer-centric relationships cross-functionally to support product developments throughout the product(s) life cycle. Subject matter expert (SME) in the technical application of product portfolio. Execution of all aspects of testing ncluding design, developing test materials, protocols, evaluation of test data, and all around support of analysis. Responsible for the execution of all aspects of clinical studies including but not limited to: site selection, pre-study visits, essential document review, site close-outs.



Job: 612995