Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
For years, Abbott’s MEDICAL DEVICES businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks.
WHAT YOU’LL DO:
Working under general supervision, is responsible for ensuring the integrity of the clinical data both in the clinical database and in the clinical files. This position is responsible for entering, reviewing, verifying, modifying and
organizing incoming clinical data. Identifies potential issues that could affect the quality of clinical data and forwards to appropriate personnel. Provides administrative support for the clinical study as needed and identifies solutions to continue to improve efficiency and quality in the data management process. Responsible for clarifying missing data with external customers. Exercises basic judgment in planning, organizing and performing work. Assures that quality of services meets internal and external customer requirements. This position will have primary responsibility for assigned studies with a basic knowledge of all studies managed by clinical data group.
- Responsible for processing incoming clinical data forms accurately and according to departmental processes. This will include the accurate and timely entry of clinical data forms into a database, the quality review and verification of forms already entered, the identification and correction of errors, and the organization of clinical documentation (clinical data forms, correspondence and other supporting clinical documentation).
- Supports discrepancy management effort by preparing data clarification forms based on review of incoming clinical data for missing/incorrect information.
- Responsible for identifying problems and discussing the issues in the area of clinical data coordination.
- Responsible for creating case report forms (CFRs), which includes tracking of all new forms and all modifications made.
- Responsible for maintaining the integrity of information stored in the clinical database through critical review of clinical data forms and the identification of discrepancies. Also responsible for ensuring the integrity of meta data study information, which includes the maintenance of hospital, physicians, and other study
- dependent tables.
- Ensure there is an adequate supply of stock for Patient data binders, Site Administrative binders and other study documentation.
- Responsible for providing administrative support for clinical studies as requested. This includes generating mail merges, faxing, copying, filing, mailings, etc.
- Responsible for providing support to the clinical evaluation department in preparation for on-site monitoring visits.
- Resolves and/or facilitates resolution of problems including identifying causes of problems to prevent reoccurrence of problems.
- Remains current on developments in field(s) of expertise.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EDUCATION & EXPERIENCE YOU’LL BRING:
- High school diploma Or other specialized training/equivalent related experience.
- Minimum 2 years Demonstrated experience as a Clinical Data Coordinator or in a comparable or closely related clinical research environment, including direct familiarity with data management processes.
- Requires knowledge of the practices and procedures of the function, company products, policies and programs.
- Demonstrated organizational skills, attentiveness to detail, ability to work under general supervision,
- and the ability to handle multiple projects simultaneously.
- Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration
- (FDA) regulations and Company operating procedures, processes, policies and rules is essential.
- Demonstrated interpersonal skills, including the ability to listen, resolve relatively complex problems,
- deal with unresolved issues, delays and unexpected events, while effectively communicating and
- maintaining rapport with field clinical engineers and study coordinators.
- Must be able to use discretion and handle sensitive/confidential information.
- Experience with FDA, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP)
- regulations as they apply to Clinical Data Management and to the clinical trial process.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the
- organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Minimal travel required.
- Ability to maintain regular and predictable attendance.
- Occasional overtime is a requirement of this position.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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