Job Closed
This listing is no longer active.
A biopharmaceutical company based in Chicago, Illinois, AbbVie makes and markets advanced therapies and medicines to treat serious illnesses and medical conditi
Clinical Research Associate
Location
South Korea
Posted
37 days ago
Salary
0
Seniority
Mid Level
Job Description
Clinical Research Associate
AbbVie
• Considered as the primary Sponsor point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning. • Aligns, trains and motivates the site staff and principal investigator with support as needed on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. • Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure activities with support as needed, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects. • Customize site engagement strategy for assigned study (ies) with support as needed. Gather local/site insights and utilize site engagement tracking tools, to report/track progress and measure impact of that strategy. • Fundamental level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. • Responsible 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. 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 compliance using a customer centric approach. • Identifies, evaluates and recommends new/potential investigators/sites with support as needed from more experienced Site Monitors. • 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.
Job Requirements
- Appropriate tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred or experience or equivalent work experience.
- Clinically related experience, in clinical research coordinating or data management preferred.
- Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
- Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
- Able to work collaboratively and cross functionally to develop and sustain working relationships.
- Demonstrate 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.
- 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 training.
- Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
- 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
Related Guides
Related Categories
Related Job Pages
More Research Analyst Jobs
Child Welfare and Education Research Analyst
ICFFounded in 1969, ICF is a global advisory and technology services company headquartered in Reston, Virginia. It delivers data-driven solutions across energy, en
• Collect, analyze, and synthesize data from surveys, interviews, focus groups, administrative data, observations, and site visits. • Collaborate closely with project teams, support client communications, and contribute to proposal development. • Support focus groups, including participant recruitment, logistics, note-taking, and summary reporting. • Design, field, and monitor surveys (online and/or paper), including instrument testing and quality checks. • Analyze quantitative data using statistical software (e.g., R, Stata, SAS, SPSS), including cleaning, merging, validation, and documentation. • Conduct and support interviews and focus groups; analyze and synthesize qualitative data using coding software (e.g., Dedoose, NVivo, Atlas.ti). • Draft reports, briefs, and presentations for technical and non-technical audiences; incorporate feedback and ensure editorial quality. • Create clear, accurate data visualizations and support project teams in using data for decision-making. • Conduct observations and participate in occasional site visits to locations nationwide. • Conduct literature reviews and contribute to research briefs, memos, and other written products.
Research Associate 1
University of MiamiThe University of Miami (UM) is a private research university with a tradition of academic excellence dating to the school's founding in 1925. As an employer, UM is one of the larg
Role Description The University of Miami/UHealth Department of Public Health has an exciting opportunity for a part time Research Associate 1. The Research Associate 1 supports research activities for the assigned division by conducting laboratory experiments on assigned research projects. The provided research role involves managing the end-to-end qualitative research process, from coordinating stakeholder interviews and ensuring IRB compliance to performing in-depth thematic data analysis and codebook development. - Understands and interprets research protocols and procedures. - Participates in the publication of significant results. - Maintains an overview of relevant research findings. - Ensures all research is undertaken according to good research practice. - Keeps abreast of current publications relative to methods, techniques, and developments within the area of research. - Collects, prepares, analyzes, dissects, and evaluates specimens or tissue cultures. - Operates and maintains laboratory equipment. - Performs a variety of routine assays, tests, and studies. - Performs calculations to complete research test results, collects data, and performs statistical analysis of laboratory results. - Adheres to University and unit-level policies and procedures and safeguards University assets. Department specific functions: - Coordinate and conduct qualitative interviews with regional stakeholders, including scheduling, sending invitations, transcribing recordings, and ensuring compliance with IRB protocols. - Support thematic analysis of qualitative interview data across multiple study regions, including codebook development, coding, and data saturation assessment. - Contribute to the second phase of the BRIDGE Study scoping review, including article screening, full-text review, and systematic data extraction. - Assist with drafting and editing peer-reviewed manuscripts, policy briefs, and blogs targeted at academic and non-academic audiences. - Support dissemination and stakeholder engagement activities, including preparation of materials for international conferences and virtual stakeholder panels. - Assist with coordination of regional working group activities and development of regional roadmaps for pandemic prevention, preparedness, response, and resilience. - Prepare and compile quarterly progress reports documenting study advances and deliverables for the AHF Global Public Health Institute. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. Qualifications - Bachelor’s degree in relevant field required. - No previous experience required. - Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands. - Teamwork: Ability to work collaboratively with others and contribute to a team environment. - Technical Proficiency: Skilled in using office software, technology, and relevant computer applications. - Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders. Benefits - Competitive salaries. - Comprehensive benefits package including medical, dental, tuition remission, and more. Company Description UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the groundbreaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America, and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research, and patient care. We're the challenge you've been looking for. The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Job Status: Part time Employee Type: Staff
• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gain in-depth understanding of the study protocol and related procedures. • Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness. • Participate & provide input on site selection and validation activities. • Perform 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 evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager. • Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Supports audit/inspection activities as needed. • Travel Requirements up to 75%. • Adhere to all aspects of Ora’s quality system. • Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements. • Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors. • Responsibilities may differ from the above based on the specific needs of the business.
Research Associate, Teaching and Learning
WestEd CareerWestEd is a community of over 1,400 researchers, practitioners, consultants, and administrative professionals committed to making a qualitative difference in the lives of youth, children, and adults. We conduct and apply research, develop evidence-based solutions, and provide consulting services across the country in both rural and urban communities to improve equitable outcomes for individuals from infancy through adulthood.
Role Description The person in this position will work across research, development, and evaluation projects, most of which include special education students, designs based on learner variability, universal design for learning (UDL); multi-tiered systems of support (MTSS); science, technology, engineering, and mathematics (STEM); artificial intelligence, educational and assistive technology, and other related special education research domains (i.e., literacy, data science, STEM, CS). This person will assist the SEPP research team with writing research proposals, including strategy, literature reviews, research design and analysis plans as well as supporting article and report writing. This person will coordinate the logistics of research, development, and evaluation projects including site recruitment, relationship building, managing research requirements and data collection. Additionally, this person will provide internal production support, coordinating budgeting, quality assurance processes, and submission. This position will report directly to the Director of Learner Variability and work directly with the SEPP research staff. The position can be home office based or based in one of our offices (Washington, DC, San Francisco, Santa Clara, Sacramento, or Seal Beach). Responsibilities - Design Research – facilitate design research including persona development, prototype development, technology development, user and usability testing, cognitive interviews, field tests, and summative evaluations. - Experimental and Evaluation Research – team management and coordination, project management, site recruitment and management, protocol and survey development, data collection processes, data management, and client reporting. - Project Coordination – coordinate, schedule, and manage field research activities such as IRB processes, MOUs, interviews, focus groups, and survey administration. - Report and Proposal Production – contribute to and/or lead the conceptualization and writing of small-to-large project reports and proposals; prepare descriptive reports, analytic sections, and evaluation reports and proposals; assist in the preparation and submission of large and small proposals. - Data Collection – develop or refine data collection instruments such as questionnaires, focus group recruitment scripts, focus group moderator guides, and classroom observation protocols; participate in or lead various data collection efforts (e.g., focus group, site visits, interviews, etc.). - Quantitative Data Management/Analysis – build, maintain, merge and manage large datasets (e.g., Common Core of Data school directory files, client implementation databases, etc.) using R or another statistical software package; effectively summarize descriptive data, and lead or contribute to conducting statistical analyses using advanced statistical methods (e.g., factor analysis, multiple regression, hierarchical linear modeling). - Qualitative Data Management/Analysis – develop coding schemes for qualitative data such as interview, observation, and text comments, have experience using qualitative analyses software (e.g., ATLAS.ti), and have knowledge and experience conducting various qualitative data analyses methods (e.g., content analyses, thematic analyses). - Facilitation/Presentation – facilitate meetings, and presentation of research findings. Interface with clients and lay persons related to data collection, analyses and reports. Communicate effectively with a range of internal and external audiences including colleagues, clients, researchers, practitioners, and lay persons. Qualifications - A minimum of five years direct work experience OR a master’s degree in special education research, design research, quantitative social science research, or related field. - Strong knowledge and experience of design research including curriculum/PD/technological prototype development, iterative user testing, setting development priorities. - Strong knowledge of research and evaluation methodology, measurement, and quantitative and qualitative data analysis. - Programming experience in at least one major statistical package (e.g., SPSS, SAS, R, or Stata). - Experience preparing research and literature reviews, coordinating and designing research, development, and evaluation projects, and writing reports of project findings. - Experience working with clients on program improvement efforts (to develop and modify program designs) and providing feedback based on evaluation findings and evidence from prior research and practice. - Ability to balance multiple projects, prioritize tasks, and communicate effectively with peers and supervisors. Capability to be adaptive to pressing requests and work with Project Directors to ensure timely completion of deliverables. - Excellent organizational skills. - Demonstrated ability to learn new technologies such as survey platforms and web management systems. - Expertise in substantive areas relevant to special educational research, evaluation, and policy analysis; such as AI, Edtech, UDL, MTSS, PBIS, STEM, literacy, significant disabilities, or educational technology. - Ability to collaborate with others and work in a team setting. - Strong technical writing and communication skills. - Ability to develop charts, tables, and other graphics for reports and presentations. - Ability to work across multiple projects and manage multiple tasks simultaneously. - Ability to provide and accept constructive criticism. - Ability to manage occasional overnight travel as part of project work. Requirements - *Note: Visa sponsorship is not available for this position. Successful candidates must be authorized to work in the United States. - WestEd conducts a criminal background check and education verification for all new hires. Any offers of employment will be contingent on receiving a clear background check in accordance with applicable law. Benefits - The full salary range for this position, WestEd level (9), is $80,000 to $125,000, but WestEd does not typically hire at or near the top of the salary range. The typical hiring range for this role is $80,000 to $100,000. The actual offer considers multiple factors, including but not limited to education, experience, internal equity, and other organizational needs. - 15% contribution toward retirement effective day 1 of employment and immediately 100% vested. - Pre-tax Flexible Spending Accounts and Health Savings Account option. - All health/welfare benefits are effective the first of the month following the hire date. - PTO: 19 days (increases to 21 days beginning the third year of employment), 12 paid holidays. - Life Insurance: value of 3x gross salary, max of 500k. - Opportunities for annual merit-based performance increases + annual incentives. - Professional development opportunities & mentorship program.



