Assistant CRA FSP

Work ScheduleEnvironmental ConditionsSummarized Purpose:Performs remote activities on assigned projects in liaison with the CRA and study Clinical Lead. Providessupport with regards to site preparedness, logistical support to the monitoring process, and assist withassigned tasks for site management and remote monitoring in accordance with SOPs and regulatoryguidelines. May be assigned limited site contact activities during study start-up, site management,recruitment and close out phases.Completes study and site management activities as defined in task matrix, andFunctions as applicable and advised for study assigned. Completes and details study-specific training. Orients and trains on any study-specific systems. Provides in-house support during pre-study assessments and with pre-studyassessment waivers, as agreed for project. Supports to customize Site ICF with site contact details, as needed. Performs remote review of EMR/EHR checklist and supports collection, asapplicable assessments. Verifies document collection and RCR submission status; updates site EDL andverifies site information. Reviews patient facing materials and review translations, as advised. Supports site staff with the vendor related qualification process, whereapplicable. Provides support by ensuring system access is requested/granted and revokedfor relevant site staff during pre-activation and subsequent course of the study. Provides support to follow-up on site staff training, as applicable. Coordinates and supports logistics for IM attendance, as advised. Supports maintenance of vendor trackers, as advised. Coordinates study/site supply management during pre-activation and subsequentcourse of the study. Supports Crucial Document collection, review and updating in systems, asapplicable. Follows up and supports on missing study vendor data like ECGs, lab samples,and e-diaries, as advised. Supports ongoing remote review of centralized monitoring tools, as advised. Supports Site payments processes by coordinating with various functionaldepartments within organization and site. Supports system updates andreconciliations, as advised and follows-up on site invoices throughout the studyperiod. Performs reconciliation tasks on assigned trials including but not limited to CRFand query status, deviations, SAEs and safety reports, as applicable. Verifies document collection status in company systems and drives action formissing/incomplete/expired documents and open document findings, as directed.EducationandExperience:Bachelor's degree in a life science rigor or related field or a Registered Nursing certification orequivalent and relevant formal academic / vocational qualification.Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0to 2 years).In some cases an equivalency, consisting of a combination of appropriate education, trainingand/or directly related experience, will be considered sufficient for an individual to meet therequirements of the role.Knowledge,Skills andAbilities: Basic medical/therapeutic area knowledge and understanding of medical terminology Ability to attain and maintain a solid understanding of ICH GCP, applicable regulations and companyprocedural documents Effective oral and written communication skills Excellent interpersonal and customer service skills Good interpersonal and time management skills and strong attention to detail, with shown ability tobalance multiple tasks efficiently and optimally Shown flexibility and adaptability Ability to work in a team or independently, as the need arises Well-developed critical thinking skills, including but not limited to critical attitude, in-depthinvestigation for appropriate root cause analysis and problem solving Proficient digital literacy with good knowledge of MS Office ability to learn and use appropriatesoftware. Leverage modern technology when applicable Ability to extract pertinent information from all study documents, electronic study data systems,CTMS and dashboards Excellent English language and grammar skill