Clinical Trial Associate

Job Title: Clinical Trial AssociateLocation: Metro Boston preferred, hybrid working modelLocation: Waltham, MARemote Flexibility: 2-3 daysweek on-siteContract Term: 6 months to start; could extend or go permExperience required:Preference is experience at CRO or small biotech for at least 1-2 years with exposure to clinical sites including site startup and IRBsIf no experience in CRO, then site experience as a study coordinatorLarger biotechpharma is okay if they've engaged directly with clinical sitesLooking for someone that can work on RFI's out for vendors, phase 1 units, setting up trackerstools, working with vendors, etcPosition Overview: The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies. The CTA will support the Clinical Trial Managers in day-to-day activities including engaging vendors, starting up and managing clinical trials. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment.Key Responsibilities: Organizemaintain tracking systems and set up tools to support the conduct of a clinical study from start-up to close-outAssist with the development and review of clinical documents including protocols, ICFs and clinical study plansSchedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actionsCoordinate and manage version control of clinical documents, prioritize multiple tasks andor projects with limited supervisionFacilitate vendor engagement from RFP distribution through to final contracting and PO set upSetup and organize Sharepoint and central study filesCoordinate training for the assigned clinical studyManage study laboratory sample tracking and vendor management supportAssist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation PackagesSupport Clinical Operations team with specific projectsEffectively communicate with study team members and work closely to address challengesMinimum Qualifications BSBA degree or equivalent and at least one year experience in clinical operations in Sponsor company with 1+ years strongly preferredKnowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out proceduresKnowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal RegulationsExperience with eTMF; ability to directly apply essential document knowledge to file documentsEffective communication, organizational and interpersonalteam skillsProficient in MS Excel, Word and PowerPoint. Knowledge of MS project and SharePoint preferred.Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelinesParticipate in inter-departmental workgroups to create or enhance processesStrong attention to qualitydetailGood organizational and time management skillsWillingness to work in a flexible environmentPreferred Qualifications Experience with global studies, using an outsourced CRO modelExperience in clinical drug development with knowledge of First in Human trialsExperience with regulatory affairs, including INDCTA submissionsExperience working on dermatology

Created: 2024-10-27