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 with a moderate level of guidance and direction, assists in the planning and conduct of Abbott clinical studies. Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures. Able to solve a range of straightforward problems and analyze possible solutions using standard procedures. 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 contribute to developing study related materials and assist with writing reports. May also assist with the oversight of vendors and committees such as core labs and safety boards.
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 review of the informed consent document to ensure all required elements are included. Assists with site nomination, qualification, and selection processes. In consultation with the assigned field clinical and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study site. Coordinates activities with study specific committees, vendor services, and core labs. 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 exit. Communicates and collaborates with all levels of employees, customers, contractors, and vendors. Applies general clinical research processes and regulatory knowledge to process improvement activities. Trains internal and external clinical professionals to ensure compliance with established protocols. Mentors less experienced clinical team members.
Other Duties: 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.
Equipment: Uses standard office equipment, including (but not limited to) personal computer, telephone, FAX, and copier.
Working Conditions: Normally works in a cubicle situated in open landscape office environment. Air conditioned. Well lighted. Moderate noise level.
Physical Demands: 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 25% travel.
- 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.
- Minimum two years clinical research experience.
- 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 and relevant clinical applications.
- The ability to work independently when necessary.
- The ability to exchange straightforward information, ask questions, and check for understanding.
- 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.