Assistant CRA

Job not on LinkedIn

🕒 June 23

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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. • 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 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. • 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.

🎯 Requirements

• Bachelor's degree in a life science discipline or related field • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 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. • Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards • Excellent English language and grammar skills.

🏖️ Benefits

• Reasonable accommodation for individuals with disabilities • Remote work options • Flexible working hours