At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
The Principal Field Clinical Engineer is an interactive resource to the study, site, and in-house personnel regarding the product under testing and the conduction of the trial. Has an active role, with participating staff and advisors, to determine appropriate patient selection, surgical planning, procedural detail, peri-operative patient management and follow-up care. Process and interpret Echo and CT studies. Provides a strong knowledge-base of the disease state so as to advise laboratory personnel on patient selection and train on proper use of device.
Under general supervision of the Manager, this position is expected to self-monitor, while providing the following responsibilities and activities:
Develop/ Refine Therapy: Actively participates in the conduction of clinical trials with participating staff and advisors, to determine appropriate patient selection, surgical planning, procedural detail, peri-operative patient management and follow-up care.
Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, conducting periodic on-site evaluations and follow-up of corrective actions.
Provides detailed feedback for product success, improvement, challenges, or any other pertinent information.
Patient-Subject Screening: Provides recommendation for identified patient-subjects to be selected for clinical trial participation.
Participates in physician advisor consultation.
Applies advanced theory understanding and advanced experience regarding technical subject matter to process and interpret Echo and CT studies of potential patient-subjects seeking to participate in trial.
Procedural Planning: Compiles patient clinical information and imaging materials to guide site care team on procedural details.
Participates in ensuring patient safety to the maximum extent possible by following applicable regulations, standards and requirements related to clinical studies, patient confidentiality, and organization practices.
Ensures validity of study information by monitoring and tracking clinical study data (CRFs, source documents, diagnostic reports, inventory logs, etc.) to identify/resolve discrepancies and obtain missing data.
Case support: Attends clinical trials.
Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
Able to develop and write clinical protocols, case report forms, and other study aids for investigational products by addressing issues from a monitoring perspective and by interacting with appropriate personnel.
As needed, coordinates logistics and provides technical support to site care teams for all cases.
Site Training: Performs on-site support training of physicians, imaging staff, hybrid room and ward personnel, including therapy and situational associated requirements for patient care.
May include providing technical support to users based on the circumstances of the clinical trial.
Establishes policy and ensures adherence to applicable ethical regulatory and clinical standards by participating in the creation, review, and approval of departmental operating procedures, code of ethics, and mission statement.
Advisor Review: Identifies, evaluates, properly reports and ensures adequate follow-up of adverse experiences by timely and accurate documentation and appropriate communication of all Adverse Event reports per internal procedures and regulatory requirements.
Prepare case summaries and other clinical data for review with Medical Advisors.
Participate in review sessions and gains additional knowledge of specific disease state. Responsible for building upon own expertise through attendance at courses, seminars, or meetings.
There is an expected focus to continue to learn catheter lab procedures and policies.
Maintains expertise in regulations for all geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.). Serves as a resource related to clinical trial regulations.
Represents the company in a professional manner at all times.
May be assigned high visibility projects related to the management of CRA or trial activities.
May need to be on-call or travel as expected for the clinical trial.
Serves a coach, advisor, trainer, and mentor for new staff, junior staff, and staff located in diverse geographies about clinical processes and the disease state.
Accountability / Scope / Budget
This position requires advanced clinical orientation with the ability to influence a variety of clinicians.
Understands business environment and relates extensive knowledge of internal and external activities to trends.
Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
May lead a project team.
Provides technical leadership.
Exercises judgment independently.
Initiates or maintains schedule for milestones; establishes priorities for individuals.
Sub-par performance will result in noncompliance with governmental regulations and erroneous decisions or recommendations would typically result in failure to achieve objectives.
Position will report to Manager of Field Clinical.
Work is performed with minimal direction.
Exercises latitude to ensure meeting all standards of the clinical study, the organization, and any governing body.
Work outcome is reviewed from a relatively long-term perspective, for desired results.
Minimum Education & Experience
BS/BA or equivalent experience required. Advanced degree meaningful; or equivalent progressive work experience. Degree in life sciences or medical training (RN, EMT, PA, etc.) A complete understanding of functional area expected.
Greater than 10 years of related work experience required, medical industry preferred.
Strong clinical orientation, experience with products for use in interventional cardiology, an expert level of understanding of the disease state.
Advanced training with imaging specific to echo cardiology and cardiac CT; other indirect imaging strongly preferred.
Expert level understanding of catheter lab policies and procedures.
Comprehensive knowledge and application of business concepts, procedures and practices. Recognized as an expert-leader of the subject matter.
Will perform this job in a quality system environment. Failure or error of decisions or recommendations would normally result in serious trial schedule delays and/or would compromise trial data integrity or compliance. Considerable expenditure of resources might be required to overcome such events.
Is assigned complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment with broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Has broad knowledge of various technical alternatives and their potential impact on the business.
Clinical Affairs / Statistics
United States of America : Remote
Yes, 75 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
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