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
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 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
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
Note: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website . Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com . About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com 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.