Clinical Research AssociateFull-timeWorkday Global Grade: 14Company DescriptionAbout AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.co.uk. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.Job DescriptionField-based CRA positionReporting to Clinical Operations ManagerExcellent development opportunities, reward and benefits packageJob OverviewAdvance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials.Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.ResponsibilitiesConsidered as the Primary Sponsor Point of contact for the investigative site. Experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening AbbVie's positioningAligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able to support, guide, and mentor junior personnel on Site Management activitiesConducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjectsUnderstanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategyAble to connect the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journeyDevelop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance."May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by managerResponsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote complianceIndependently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.QualificationsAppropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred or experienceIndependent clinical research monitoring experience of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoringKnowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trialsKnowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policiesDemonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholdersDemonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlinesAbility to leverage technology, tools and resources to provide customer centric support based on the health of the siteExcellent interpersonal skills with strong written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and trainingAbility to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issuesActs with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.Additional InformationAbbVie's UK offices in Maidenhead prioritize accessibility and employee well-being, creating a welcoming environment for everyone. The office includes a large car park for easy access, as well as step-free entry, accessible restrooms, and elevators to accommodate individuals with mobility challenges. The workspace features assistive technologies and adaptable workstations, fostering an inclusive culture. Additionally, there is a dedicated quiet zone for those who prefer to work without distraction. This area maximizes natural light and is strategically positioned for easy access with minimal noise disturbances. If you need specific information or have questions about accessibility arrangements, please let us know during the process.AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.htmlBy clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice
