1 Clinical System Support Specialist II Job in Princeton, NJ
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Clinical System Support Specialist II
$87k-115k (estimate)
Full Time
1 Month Ago
SPECTRAFORCE is Hiring a Clinical System Support Specialist II Near Princeton, NJ
Title: Clinical System Support Specialist II
Location: Santa Clara, CA or Princeton, NJDuration: 12 Months 50% travel Required
Job Description
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
Location: Santa Clara, CA or Princeton, NJDuration: 12 Months 50% travel Required
Job Description
- 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 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)
- 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. For interviews, candidates should be familiar with i-STAT handheld blood analyzer
- 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
- Cinical 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
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
Job Summary
JOB TYPE
Full Time
SALARY
$87k-115k (estimate)
POST DATE
08/01/2024
EXPIRATION DATE
09/25/2024
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