Clinical Research Associate - FSP
Czechia, Remote 职位编号 R0000022269 类别 Clinical Trials关于这个职位
Position Purpose:
The Clinical Research Associate (CRA) will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Primary Duties:
Develops strong site relationships and ensures continuity of site relationships through all phasesof the trial
Performs clinical study site management/monitoring activities in compliance with ICH-GCP,
Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associateddocuments
Gains an in-depth understanding of the study protocol and related procedures
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve SiteReady
Participates & provides inputs on site selection and validation activities
Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased
- Subjects’ right, safety and well-being are protected
Conducts site visits including but not limited to validation visits, initiation visits, monitoringvisits, close-out visits and records clear, comprehensive, and accurate visit & non-visit contactreports appropriately in a timely manner
Collects, reviews, and monitors required regulatory documentation for study start-up, studymaintenance and study close-out
Communicates with Investigators and site staff on issues related to protocol conduct,recruitment, retention, protocol deviations, regulatory documentation, site audits/inspectionsand overall site performance
Identifies, assesses, and resolves site performance, quality or compliance problems and escalatesper defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Associate-Manager (CRAM)/Clinical Research Manager (CRM), Partner Line Manager (PLM)
Manages and maintains information and documentation in CTMS, eTMF and various othersystems as appropriate and per timelines
Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required
Supports and/or leads audits/inspection activities as needed
Performs co-monitoring visits where appropriate
Experience or ability to support and/or lead audit/inspection activities as needed
Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
Adheres to EP and Client SOPs and processes
Skills and Education:
B.A./B.S. preferred with a strong emphasis in science and /or biology
Minimum 2 years of direct site management (monitoring) experience in bio/pharma/CROrequired
Note: No compromise on minimum monitoring experience however specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs
Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
Good understanding and working knowledge of clinical research, phases of clinical trials, currentGCP/ICH & country clinical research law & guidelines.
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to workwithin these guidelines
Hands on knowledge of Good Documentation Practices
Proven skills in Site Management including management of site performance and patientrecruitment
Demonstrated high level of monitoring skill with independent professional judgement
Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet andmobile devices) and ability to adapt to new IT applications on various devices
Ability to understand and analyze data/metrics and act appropriately
Capable of managing complex issues, working solution – oriented
Performs root cause analysis and implements preventative and corrective action
Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
Demonstrated high level of monitoring skill with independent professional judgement
Able to work highly independently across multiple protocols, sites, and therapy areas
High sense of accountability / urgency
Ability to set priorities and handle multiple tasks simultaneously in a changing environment
Works effectively in a matrix multicultural environment
Ability to establish and maintainculturally sensitive working relationships.
Demonstrates commitment to Customer focus
Works with high quality and compliance mindset
Positive mindset, growth mindset, capable of working independently and being self-driven
Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices
Ability to travel domestically and internationally approximately 65%-75% of working time.
Expected travelling ~2-3 days/week
Current driver’s license required
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