Assistant CRA Job at Thermo Fisher Scientific | Apply Now
This Assistant CRA Job is a full-time opportunity in Athens, Greece, offering candidates the chance to contribute to innovative clinical research projects while working remotely.
- Position: Assistant CRA
- Location: Athens, Greece – Fully Remote
- Job Id: R-01364001
- Category: Clinical Research
About the Company
Thermo Fisher Scientific is a leading global contract research organization (CRO) that provides comprehensive drug development and lifecycle management services. With a strong focus on clinical research, PPD supports pharmaceutical companies and biotech firms in bringing new therapies to market. The organization is committed to improving health outcomes through scientific expertise and operational excellence.
Assistant CRA Job Description
Join PPD as an Assistant Clinical Research Associate and make an impact at the forefront of innovation. The Assistant Clinical Research Associate will support site preparedness, logistical support, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines.
Eligibility Criteria
Eligibility Criteria for Assistant CRA Job include:
- Bachelor’s degree in a life science discipline or related field or relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
Required Skills
- 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.
- 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.
Assistant CRA Job – Key Responsibilities
- 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.
- 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.
- 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.
Qualified candidates are encouraged to seize this opportunity to join Thermo Fisher and contribute to groundbreaking clinical research initiatives. Applications for this Assistant CRA Job should be submitted at the earliest to ensure consideration.
