The World Leader In Serving Science
Assistant CRA
Location
Romania
Posted
5 days ago
Salary
0
Seniority
Mid Level
Job Description
Assistant CRA
Thermo Fisher Scientific
• 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 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. • 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 company 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 CRA and as per Task Matrix. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Job Requirements
- Bachelor's degree in a life science discipline or related field or a Registered Nursing certification 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)
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company 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.
Benefits
- Professional development opportunities
- Remote work options
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