Assistant CRA
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Job Description
Assistant CRA performing remote monitoring activities for clinical trials across the UK. Engaging in site management, logistical support, and documentation duties in compliance with guidelines.
Responsibilities:
- 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
- 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
- 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
Requirements:
- Bachelor's degree or higher in Lifesciences
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year)
- Valid driving license for the UK
- 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
- Excellent English language and grammar skills
Benefits:
- Health insurance
- Professional development opportunities
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