Candidates must be local to Santa Clara, CA or Princeton, NJ (Position is NOT remote, 50% travel) Candidate will be onsite at client sites and will be required to travel within United states 50% of the time.

3 - 6 years of experience with CRA tasks such as remote monitoring, SOP creation, site selection setup, setup execution, protocol development; medical device experience is preferred.

UPDATED GUIDELINES WHEN RECRUITING FOR CANDIDATES:

• Preferred if they have at least one CRA job experience from the sponsor side
• If they have only CRO-based experience, then being coachable is required
• We have found that many CRO-focused candidates have a more narrowed experience with repetitive core CRA tasks directed by a manager (we understand this is a common CRO model with team resources assigned to discrete functional tasks);
• Client’s model has more of an expectation that Sr/cras will be flexible and able to anticipate, pivot, independently lead tasks and lead others (so we screen for people who can: wear multiple hats (using knowledge of regulations, data management, document creation etc) throughout all phases of the study, be able to troubleshoot during study execution and perform with little to medium oversight)
• If they have focused mostly on site data monitoring, this is a flag; covering all visit types ~evenly is needed
• We look for experience in creating (not just reviewing) clinical documents such as training materials for sivs, protocols, crfs, icfs, brochures
• Experience participating in Data Management activities like UAT (user acceptance testing) and Study Reviews can serve to distinguish a preferred candidate
• Experience/knowledge with US sites and US regulations is definitely considered as most of our studies need this having device and/or IVD experience

Knowledge:

• International Harmonized /Committee Good Clinical Practices, IHC/GCP.
• Current Good Manufacturing Practice 21 CFR Part 820 is an asset.
• Require 3-6 years relevant work experience.

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).

Travel up to 30% of the time domestically and / or internationally may be required.

• We have 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 (i-STAT 1 and Alinity).
• 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 resources 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).
• Screening for CRAs with sponsor initiated IVD, clinical study, test lab experience from science/health sciences backgrounds may help.

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 client 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)

Job Type: Contract

Pay: $48.00 - $50.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• site monitoring: 3 years (Preferred)
• work with sites for close out of the studies: 3 years (Preferred)
• protocol development: 3 years (Preferred)
• CRO or Medical Device or Pharma industry: 3 years (Preferred)
• clinical studies: 3 years (Preferred)

Ability to Commute:

• Princeton, NJ 08540 (Required)

Work Location: In person