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A biopharmaceutical company based in Chicago, Illinois, AbbVie makes and markets advanced therapies and medicines to treat serious illnesses and medical conditi
Senior Clinical Research Associate
Location
South Africa
Posted
83 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Research Associate
AbbVie
• Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients • 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 • Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans • Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy • Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance • Supports local onboarding of more junior CRAs • Responsible for activities as assigned by manager
Job Requirements
- Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing)
- Minimum of 3 years of clinically related experience, of which a period of 5 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area
- Familiar with risk‐based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
- Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders
- Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Ability to leverage technology, tools and resources to provide customer centric support based on the health of the site
- Acts 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.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. • Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. • Collaborating with investigators and site staff to facilitate smooth study conduct. • Performing data review and resolution of queries to maintain high-quality clinical data. • Contributing to the preparation and review of study documentation, including protocols and clinical study reports
• Oversee the operational aspects of clinical trial conduct at investigational sites to ensure data integrity, regulatory compliance, and adherence to Good Clinical Practice (GCP) guidelines. • Support multiple clinical trials across various therapeutic indications and monitor site performance, resolving issues, and facilitating communication between sponsor and site personnel. • Evaluate clinical trial resourcing requirements for qualification (SQVs), training (SIVs), monitoring (IMVs) and support of sites during the conduct of the trials. • Work with multiple trial sites and multiple studies of varying indications simultaneously. • Develop and maintain a monitoring plan for assigned clinical trial(s). • Liaise with external clinic and/or hospital investigators and associated staff conducting the trial as required. • Oversee the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study. • Oversee site activation process for each study. • Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring. • Track patient enrollment and recommend solutions to trial site staff to increase appropriate enrollment of qualified subjects. • Provide support for the processing of data queries, deviations, adverse events, etc. • Write monitoring visit reports. • Develop and execute a plan to close trial sites on completion of the trial and perform associated close-out activities.
Research Consulting Lead - Experience Strategy & Insights
CenterWellCenterWell Pharmacy provides convenient, safe, reliable pharmacy services and is committed to excellence and quality. Through our home delivery and over-the-counter fulfillment services, specialty, and retail pharmacy locations, we provide customers simple, integrated solutions every time. Cares for patients with chronic and complex illnesses. Offers personalized clinical and educational services to improve health outcomes and drive superior medication adherence. CenterWell, a Humana company, creates experiences that put patients at the center. As the nation’s largest provider of senior-focused primary care, one of the largest providers of home health services, and the fourth largest pharmacy benefit manager, CenterWell is focused on whole-person health by addressing the physical, emotional, and social wellness of our patients. Part of Humana Inc. (NYSE: HUM). Offers stability, industry-leading benefits, and opportunities to grow yourself and your career. Employs more than 30,000 clinicians committed to putting health first. Provides flexible scheduling options, clinical certifications, leadership development programs, and career coaching.
Role Description The Research Consulting Lead – Experience Strategy & Insights plays a critical role on the CenterWell Customer Experience (CWCX) team. You will transform customer signals into clear insights, priorities, and decision confidence for business leaders. - Partner with Journey Transformation, VOC Insights, Analytics, Digital Products, and Business Units. - Define insight strategies, design and implement research, integrate multiple data sources, and connect experience insights to outcomes. - Operate as a strategic consultant, ensuring research and measurement efforts directly inform prioritization, investment decisions, and experience improvement roadmaps across CenterWell. - Report to the Director, Strategy Advancement. Qualifications - Bachelor's degree in social science, psychology, anthropology, human factors, market research, business, or related field. - 8+ years of experience in experience strategy, research consulting, customer insights, CX analytics, or human-centered research. - Qualitative and quantitative research design and synthesis skills. - Competence to translate research into strategic insight and executive-ready recommendations. - Experience linking customer experience insights to outcomes and metrics. - Influence across teams. - Facilitation and storytelling skills. - Working knowledge of CX measurement approaches (e.g., NPS, CSAT, or journey-level metrics). Requirements - Define and lead experience insight strategies with care for CenterWell, LOB, and enterprise priorities. - Improve CX insight experience by integrating VOC, research, operational data, and analytics into a cohesive understanding of customer experience. - Ensure insights are decision-ready, prioritized, and tied to articulated business questions and outcomes. - Shape strategic plans to improve organizational insights capability across developing, foundational, and advanced levels. - Lead qualitative and quantitative research to answer business and experience questions. - Validate hypotheses coming from VOC trends, journey analytics, and partner assumptions. - Partner with VOC Insights & Analytics teams to size impact, identify drivers, and connect experience insights to business measurements. - Ensure methodological thoughtfulness, insight quality, and practical applicability of research outputs. - Define, socialize, and maintain experience measurement frameworks that connect customer outcomes to operational and financial performance. - Translate complex insight into clear narratives, possible effects, and recommendations tailored to executive and partner needs. - Support prioritization decisions by clarifying trade-offs, risks of inaction, and potential value creation. - Identify systemic experience issues and new opportunities across journeys, channels, and assets. - Partner with teams (within CWCX and across BUs) to assess desirability, viability, and feasibility when evaluating experience opportunities. - Support development of prioritized CX portfolios and roadmaps with care for business strategy. - Ensure experience insights inform where we invest, sequences work, or deprioritizes efforts. - Be a trusted strategic advisor to business, product, digital, clinical, and operations leaders. - Facilitate structured discussions and working sessions to agree on problem definition, decision clarity, and success criteria. - Collaborate with partners by providing insight, prioritization guidance, and measurement plans that inform downstream design and implementation. - Improve the voice of the customer in enterprise decision-making through compelling storytelling and evidence. Benefits - Competitive benefits that support whole-person well-being. - Medical, dental and vision benefits. - 401(k) retirement savings plan. - Time off (including paid time off, company and personal holidays, volunteer time off, paid parental and caregiver leave). - Short-term and long-term disability. - Life insurance and many other opportunities. Company Description Humana Inc. (NYSE: HUM) is a leading U.S. healthcare company. Through our Humana insurance services and our CenterWell healthcare services, we make it easier for the millions of people we serve to achieve their best health – delivering the care and service they need, when they need it.
Clinical Research Associate
GE HEALTHCAREGE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Role Description The Caption Health SBU focuses on clinical applications that aid in early disease detection, using AI to assist in conducting ultrasound scans. Caption Health is searching for a Clinical Research Associate (CRA), preferably with Medical Device experience. As a CRA, you will be responsible for supporting Caption Health sponsored medical device clinical trials (software as a medical device) and research through site monitoring activities to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. You will also provide support in start-up, enrollment, follow up and closure of clinical trial activities, while partnering with Clinical Operations teams (Data Managers, Statisticians, System Admin) and Clinical Project Managers to ensure strategic planning, resourcing, execution, and oversight of monitoring deliverables. Essential Responsibilities - Serves as the primary point of contact between the research site and GE HealthCare for all monitoring activities for multiple clinical trials across a range of medical devices and program teams, ensuring compliance with Good Clinical Practices, ISO 14155, and other applicable regulations. - Conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records. - Provides clear written communication to clinical sites and project team members through monitoring reports, follow up letters, study memos, and general correspondence. Thorough documentation and proper escalation of issues is essential in all visit reports. - Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification, and training records. - Ensures any identified protocol deviations are addressed, clearly communicated, documented, and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. - Ensures that all reportable events are identified, clearly documented, and reported per protocol and applicable requirements/regulations. - Attends internal and external meetings as necessary to facilitate discussion and decisions for monitoring strategy pertaining to study, regulatory, or GCP specific requirements. - Responsible for developing Study Monitoring Plans, Monitoring Visit Reports (SQV, SIV, IMV, COV), follow-up letters, and Study/Monitoring Risk Assessments. - Participates in team review and maintenance of QMS work instructions governing Study Monitoring, always striving to identify and implement opportunities for improvement. Qualifications - Bachelor's degree or equivalent - 4 years experience in clinical research; applicable CRA experience - Proven communication skills, both written and verbal - Must be willing to travel as required (up to 60%). - Working knowledge of clinical research operations and documentation - Proven ability to drive multiple projects and initiatives in a cross functional environment while leveraging key stakeholders and engaging end users. Eligibility Requirements - This position is based in the United States only. Legal authorization to work in the U.S. is required. GE HealthCare may agree to sponsor an individual for an employment visa now or in the future if there is a shortage of individuals with particular skills. - Must be willing to travel as required. Up to 60%. Desired Characteristics - Well organized and structured, high attention to detail. - Ability to work independently and systematically. - Knowledge of Quality Management Systems (QMS) including experience with GDP and CAPA. - 6 years experience as CRA Compensation For U.S. based positions only, the pay range for this position is $132,000.00-$198,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). Benefits - Medical, dental, vision - Paid time off - 401(k) plan with employee and company contribution opportunities - Life, disability, and accident insurance - Tuition reimbursement Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance No

