Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Late Phase Clinical Research Associate I or II
Homebased in UK
IQVIA- Real World Evidence Solutions has exciting permanent career opportunities on offer for CRAs at either the CRA I or CRA II level.
Within IQVIA, the Real World Evidence business unit employs over 1,000 dedicated staff to design, implement and manage real-world and post-marketing studies. As healthcare stakeholders increasingly need evidence to support regulatory, reimbursement and prescribing decisions, the IQVIA RWE team offers a comprehensive evidence approach to meet our customer's unique needs for demonstrating safety, effectiveness and quality.
- 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
- 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.
- 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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good 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
- Good 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
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's Degree preferably in life science, and some prior monitoring experience.
WHAT WE CAN OFFER YOU:
At IQVIA you have the opportunity to make a lasting impact on our customers, the industry, patient health around the world, and your career.
We are committed to rewarding your contributions with a combination of competitive salaries, comprehensive benefits, and an award winning culture.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
Job ID: R1054363