Clinical Study Specialist Position Available In Somerset, New Jersey

Job Description:

Job Description The Clinical Study Specialis t (CSS) providestechnical and administrative support to the clinical study team(s)responsible for clinical trial execution. The CSS may be assignedto support the execution of one or more studies across a program.

The CSS receives assignments from the Clinical Study Lead orClinical Study Associate Manager. The CSS will support internallysourced studies and studies out-sourced to Clinical ResearchOrganizations (CROs). This role is an onsite position. Fully remoteis not possible for this role. In this role, a typical day mightinclude the following: Organizes and delivers analyzable reportsand metrics to the clinical study lead Schedules and coordinatesmeetings, prepares agendas, presentation materials and minutes forclinical study team meetings and other study related meetingsCollates data for assessments such as feasibility and siteselection and reviews site usability database Contributes to reviewof study documents such as informed consent forms, case reportforms and facilitates study document reviews per company standardoperating procedures Compiles study manuals including but notlimited to: study reference binders and manuals and maintainsversioning of study reference materials (e.g., regulatory,pharmacy, and laboratory binders Collates materials for trainingand investigator meetings Tracks site activation, enrolment andmonitoring visits to projected plans, and escalate any issues ordelays with site activation or deviations from monitoring planMonitors and updates investigator/site status for the trial, andsupports with clinical trial registry postings Performs scheduledreconciliations of study Trial Master File (TMF) with clinicalstudy lead guidance Ensures scheduled reports are received (i.e.1572 reportable changes, financial disclosure form) Manages andmaintains team SharePoint and/or shared drive sites, as neededCommunication with sites as directed and maintains site contactinformation Contributes to line listings review for Blind DataReview Meeting (BDRM) May manage or contribute to oversight ofThird Party Vendors (TPV) Tracks and monitors close out activitiesstudy close-out documents (1572s, Investigational Productreconciliation, Financial Disclosures, etc.) and CRA close-outvisits Participates in Standard Operating Procedures (SOPs)revisions or departmental initiatives Proactively recommendsprocess improvement initiatives for the department May require 25%travel This role might be for you if you have: Attention to detailsfor the ability to track information and deliver on assigned studyactivities Good communication and interpersonal skills; ability tobuild relationships internally and externally Ability to beresourceful and to demonstrate problem solving skills Demonstratethe ability to proactively assess information and investigateimpact on clinical trials Ability to acquire working knowledge intrial management systems and MS applications including (but notlimited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMFProactive and self-disciplined, ability to meet deadlines,effective use of time, and prioritization Basic familiarity withmedical terms and clinical drug development Awareness of ICH/GCP Inorder to be considered , a Bachelors degree with 2 years ofrelevant experience.

In lieu of a Bachelors Degree, AssociatesDegree with 5 years of relevant experience. Does this sound likeyou? Apply now to take your first step towards living the RegeneronWay! We have an inclusive and diverse culture that providescomprehensive benefits, which often include (depending on location)health and wellness programs, fitness centers, equity awards,annual bonuses, and paid time off for eligible employees at alllevels! Regeneron is an equal opportunity employer and allqualified applicants will receive consideration for employmentwithout regard to race, color, religion or belief (or lackthereof), sex, nationality, national or ethnic origin, civilstatus, age, citizenship status, membership of the Travelercommunity, sexual orientation, disability, genetic information,familial status, marital or registered civil partnership status,pregnancy or parental status, gender identity, gender reassignment,military or veteran status, or any other protected characteristicin accordance with applicable laws and regulations. The Companywill also provide reasonable accommodation to the knowndisabilities or chronic illnesses of an otherwise qualifiedapplicant for employment, unless the accommodation would imposeundue hardship on the operation of the Company’s business. Forroles in which the hired candidate will be working in the U.S., thesalary ranges provided are shown in accordance with U.S. law andapply to U.S.-based positions. For roles which will be based inJapan and/or Canada, the salary ranges are shown in accordance withthe applicable local law and currency. If you are outside the U.S,Japan or Canada, please speak with your recruiter about salariesand benefits in your location. Please note that certain backgroundchecks will form part of the recruitment process. Background checkswill be conducted in accordance with the law of the country wherethe position is based, including the type of background checksconducted. The purpose of carrying out such checks is for Regeneronto verify certain information regarding a candidate prior to thecommencement of employment such as identity, right to work,educational qualifications etc. Salary Range (annually) $92,500.00- $151,100.00