Veterans at Abbott
Abbott Clinical Research Associate I in St. Paul, Minnesota
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 103,000 colleagues serve people in more than 160 countries.
Working under direct supervision, assists in the planning and conduct of SJM clinical studies. Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and SJM Standard Operating Procedures. Performs routine assignments in this entry level position. Uses existing procedures to solve routine or standard problems. Focus is on site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing and trending adverse events and protocol deviations. May also contribute to the development of study related materials.
Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include but is not limited to: Assists in the development of study related materials such as: patient brochures, patient recruitment material, and presentations. Assists in the development and review of informed consent document to ensure all required elements are included. In consultation with the assigned field clinical and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study site. Reviews and analyzes data and documents for accuracy and completeness. Creates and processes data queries. Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits. Reviews and processes product complaints and adverse events as soon as they are reported. Serves as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol-related issues and escalating as appropriate. Ensures the clinical study site adheres to the assigned protocol and all applicable regulatory standards. Notify appropriate study management when concerns exist. Communicates and collaborates with all levels of employees, customers, contractors, and vendors. Applies general clinical research processes and regulatory knowledge to process improvement activities.
Have a good understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about Abbott devices and therapies.
May make additional contributions as assigned.
Uses standard office equipment, including (but not limited to) personal computer, telephone, FAX, and copier.
Normally works in a cubicle situated in open landscape office environment. Air conditioned. Well lighted. Moderate noise level.
Primarily sitting. Some walking. Light effort related to moving, lifting and using office supplies and standard office items. Performs tasks which regularly require good correctable vision and hand/eye coordination.
This position may require up to approximately 10% travel.
Required: A Bachelor degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees.
Familiarity with Microsoft word, Excel and Outlook programs.
The ability to generally work independently, but seek guidance when necessary.
The ability to exchange straightforward information, ask questions, and check for understanding.
Desired: A general familiarity with clinical trials research processes. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.
Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).
Work habits include organization, coordination of many tasks, accuracy, and attention to detail.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org