Clinical Trial Associate

Job Description The Clinical Trial Associate serves as the primary point of contact for administrative support to the site and clinical trial team. The Clinical Trial Associate is also responsible for coordinating the day to day clinical study activities and maintaining the logistical aspects of clinical trials in compliance with protocol, International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP), local regulations, applicable Standard Operating Procedures (SOPs) and project-specific requirements. Responsibilities TheClinicalTrialAssociatewillbeinvolvedinmostactivitiesinpreparationforthesetup, conduct, and completion of a clinical trial. This includes, but is not limited to: Primary TrialMasterFile Duties Assume primary responsibility for the setup, development, maintenance, and correspondence of the Trial Master File (TMF) for studies assigned Set up and maintain electronic filing systems/set up of the Investigator Site File (ISF) Track Ethics/Regulatory submissions and approvals for studies Prepare distribute, track, and file essential clinical trial documentation Coordinate archiving of study documentation CRAand Study Team Support Assist the Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines Serve as the point of contact for CRA assistance with TMF or study related material support Arrange and participate in the organization of investigator meetings and study team meetings including taking and distributing minutes and tracking of the final document StudyManagement Support Assist the Clinical Trial Manager in the site selection process Assist in initial composition of Operations Manual, Pharmacy Binder, and Investigator Site File (ISF) Binder, etc. Manage and maintain study documents and trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits and Medical equipment for sites Ensure that any clinical trial databases/tracking tools are set up and maintained throughout the trial Create and maintain study contact lists for team/sites/3 rd parties Review study mailbox and file emails in appropriate mailbox folders Assist in preparation and distribution of study newsletters /study correspondence to all participating sites on an ongoing basis Set up of finance systems accurately, process invoices and track payments for the trial for investigator and vendor payments Assist with collating, tracking and shipping case report forms (CRFs) and data queries to Data Management General study filing Otherpossibletasksmay Include Assist with designing of study logs, source document template, etc. Arrange translation of advertisement material and patient documents Assist CRAs on monitoring visits Reorder clinical drug supplies for sites Other duties as assigned Qualifications Bachelor’s degree (or equivalent) in scientific discipline 1 year of relevant experience in healthcare setting, preferably within the pharmaceutical/biotech industry (or alternatively, an equivalent combination of education, training and experience). Prior experience in clinical research is preferred. Working knowledge of ICH-GCP guidelines and FDA regulations Strong verbal and written communication skills Ability to work effectively both independently and in a team environment Strong organizational and planning skills Excellent interpersonal and professional skills Excellent time management skills with the ability to prioritize responsibilities and multitask Strong administrative skills Excellent documentation and file management skills Self motivated and detail oriented Proficient in Microsoft Office and able to learn appropriate software About Us With a legacy spanning more than 80 years, NSF leverages science and innovation to improve human and planet health. We provide science-driven, independent testing, inspection, certification, and advisory services and develop the very standards that drive the food, water, and life sciences industries worldwide. We empower our clients to navigate shifting regulations to improve consumer health, safety, and quality of life. One of our core values is We Are One NSF. This means that while we’re one team, we embrace the cultural, ethnic, language, and demographic diversity that reflects the societies in which we live and work. Come join a team that makes a difference in the world. More information about NSF can be found at nsf.org. NSF is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability. Notice to Agency and Search Firm Representatives: Please note that NSF is not accepting unsolicited resumes from agencies/search firms for this role. Resumes submitted to an NSF employee by a third-party agency without a valid written & signed search agreement between NSF and said third-party agency will become the sole property of NSF. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral. Thank you. About The Team From research to patient, NSF's expert team provides comprehensive regulatory, quality and clinical support to pharmaceutical, biotech, medical devices, in-vitro diagnostics, and combination products clients across the product life cycle to navigate complex regulations and industry challenges. #J-18808-Ljbffr NSF