IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Clinical Research Associate I, II or Senior CRA
Homebased UK position
IQVIA™ Real-World Insights teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers and patients. Our approach is unique in the industry and is defining the way companies can develop and apply real-world evidence to provide deeper insight about market dynamics, therapy area changes, outcomes research and other scientific insights. We are collaborative, intellectually curious, entrepreneurial, and constantly looking for opportunities to harness the value of real-world evidence in a constantly evolving industry.
We seek an experienced Senior CRA to join our Real-World Evidence team based in the United Kingdom.
Ensure clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements by engaging with assigned sites. Workload will include complex projects.
- May perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.
- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
- Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
- Execute assigned work efficiently and adhere to project timelines and financial goals; may provide Site and Patient Services performance metrics and make recommendations based on their findings.
- Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
- May assist in preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
- May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities. May act as point of contact for other CRAs on the project.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Strong knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Strong written and verbal communication skills in applicable languages, and business level command of English
- Strong organizational, interpersonal and problem-solving skills
- Strong attention to detail
- Working time management skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites
You will be contacted by one of our recruiters to arrange a prescreen call should your background be relevant for this opportunity who will be able to give you more information on this team and the opportunity and also explain the assessment process to you for this role.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
Job ID: R1087877