Assistant CRA at Thermo Fisher Scientific
1 month ago
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity.
Position Overview:
Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. 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 and regulatory guidelines. May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.
Responsibilities for the role:
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 project.
Supports to customize 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 review 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.
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 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.
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.
Keys to Success:
Education and Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 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 tried 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
Advanced digital literacy 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
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