This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
Job Description: The Assistant CRA performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA, and study CTM. Provides support regarding site preparedness, logistical support to the monitoring process, and assists with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. May be assigned limited site contact activities during study start-up, site management, recruitment, and close-out phases.
Essential Functions: Completes study and site management activities as defined in task matrix, and as 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-study assessment waivers, as agreed for the project.Supports customizing Site ICF with site contact details, as needed. Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.Verifies document collection and RCR submission status; updates site EDL and verifies site information.Reviews patient-facing materials and translations, as directed. Supports site staff with the vendor-related qualification process, where applicable.Provides support by ensuring system access is requested/granted and revoked for 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 directed.Supports maintenance of vendor trackers, as directed.Coordinates study/site supply management during pre-activation and subsequent course of the study.May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.May perform a specific role profile for FSP opportunities according to Client requests.Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.Supports Essential Document collection, review, and updating in systems, as applicable.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 functional departments within the organization and site. Supports system updates and reconciliations, as directed, and follows up on site invoices throughout the study period.Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs, and safety reports, as applicable.Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed.Education and Experience: Bachelor's degree or equivalent and relevant formal academic/vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements 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 CRG procedural 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 to handle 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-depth investigation for appropriate root cause analysis, and problem-solving.Proficient computer skills with good knowledge of MS Office; ability to learn and use appropriate software. 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.
#J-18808-Ljbffr