Description de l'offre
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.
In Germany, Abbott has approximately 2,700 employees working in manufacturing, research and development, logistics, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn and Witten. St. Jude Medical is now Abbott.
Abbott / St.Jude Medical is seeking an experienced, high caliber
Field Clinical Research Associate (m/f)
Working with a moderate level of remote guidance and direction, is accountable for clinical study site maintenance, data and source documentation collection, as well as field monitoring of clinical trials for Abbott.
- This position ensures compliance to the study protocol and Monitoring Plan by ensuring completeness and accuracy of data as well as compliance with domestic and international regulations, 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 adverse events and protocol deviations.
- Maintains accurate, detailed and complete records of monitoring visits. In consultation with the assigned Field Clinical Engineer or designee and/or appropriate in-house personnel, coordinates the initiation of the clinical site.
- Work requires the application of theoretical principles and creative/analytical techniques.
- Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
Impact this role will have at Abbott:
- Monitors clinical studies at sites (hospitals) in an assigned territory (and others as requested) to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits
- Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects - This may include, but is not limited to: - Reviewing data and source documentation from investigational sites for accuracy and completeness
- Ensuring adverse events and protocol deviations are reported in an efficient manner
- Ensuring that device complaints and malfunctions are reported according to Policies and Procedures
- Resolving and/or facilitating resolution of problems including identification of cause and actions to prevent re-occurrence
- Coordinates with study teams, field clinical engineers or designee to: Enroll sites into new and ongoing clinical studies - Facilitate enrollment of study subjects via site coordinators - Facilitate resolution of data queries and action items at clinical sites - Promptly reports the findings of monitoring visits according to processes
- Collaborates with in-house teams to ensure complete submission of study documents
- Participates in conference calls and training sessions
- Trains site personnel to ensure compliance with the study protocol and local regulations
- Mentors less experienced clinical team members as requested
- A Bachelor's degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bio-engineering, 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
- Basic personal computer skills including a working familiarity with word processing software and relevant clinical applications
- The ability to work independently and function within a dynamic, global team environment
- The ability to exchange straightforward information, ask questions, and check for understanding
- Proficient level of English and German is a must. A third language would be also very much valued
- A general familiarity with clinical research processes
- Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment
- Certification by an industry-recognized professional society (i.e. Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or accredited institution)
Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company's success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.
Do you like the sound of this job and think you've got what it takes? Then send us your CV today. We look forward to receiving your application.
JOB FAMILY:Research and Discovery
DIVISION:MD Medical Devices
LOCATION:Germany : Remote
TRAVEL:Yes, 75 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment