Assistant CRA

Job Description

Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and studyCTM. Provides support with regards to site preparedness, logistical support to the monitoring process,and assist with assigned tasks for site management and remote monitoring in accordance with SOPs andregulatory guidelines. May be assigned limited site contact activities during study start-up, sitemanagement, recruitment and close out phases.Essential Functions and Other Job Information:EssentialFunctions Completes study and site management activities as defined in task matrix, andas applicable and directed for study assigned. Completes and documents study-specific training. Orients and trains on any CRG/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 directed. 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 appplicable. Coordinates and supports logistics for IM attendance, as directed. Supports maintenance of vendor trackers, as directed. Coordinates study/site supply management during pre-activation and subsequentcourse of the study. Supports Essential 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 directed. Supports ongoing remote review of centralized monitoring tools, as directed. Supports Site payments processes by coordinating with various functionaldepartments within organization and site. Supports system updates andreconciliations, as directed 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 CRG systems and drives action formissing/incomplete/expired documents and open document findings, as directed. May perform other assigned site management tasks, as directed by RCRA and asper Task Matrix. May perform a specific role profile for FSP opportunities according to Clientrequests. Maintains & completes administrative tasks such as expense reports andtimesheets in a timely manner.Job Complexity Works on problems of limited scope. Follows standard practices and procedures inanalyzing situations or data from which answers can be readily obtained.Job Knowledge Learns to use professional concepts. Applies company policies and procedures toresolve routine issues.SupervisionReceivedNormally receives detailed instructions on all work.BusinessRelationshipsContacts are primarily with immediate supervisor, and other personnel in thedepartment. Builds stable working relationships internally.Qualifications:Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious 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 and Abilities: Basic medical/therapeutic area knowledge and understanding of medical terminology Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and CRGprocedural documents Effective oral and written communication skills Excellent interpersonal and customer service skills Good organizational and time management skills and strong attention to detail, with proven ability tohandle multiple tasks efficiently and effectively Proven flexibility and adaptability Ability to work in a team or independently, as required Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving Proficient computer skills 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 skills