Abbott Senior Field Clinical Research Associate- Indianapolis in Indianapolis, Indiana
At Abbott, we're committed to helping people live their 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, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Sr. Field Clinical Research Associate. Working with a minimal 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. 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 Standard Operating Procedures. Able to solve a range of straightforward and complex 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. Stays abreast of and consults on technical advancements. Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues. Exercises judgment in planning and organizing work; monitors performance and reports status. Identifies areas of process improvement and provides solutions to Management. Mentors new FCRAs as requested by FCRA Management and manages and tracks the progress of the mentee and reports progress to FCRA Management.
Impact this role will have on Abbott:
Monitors clinical studies at sites 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 Abbott Policies and Procedures
Resolving and/or facilitating resolution of problems including identification of cause and actions to prevent reoccurrence
Coordinates with study teams, field clinical engineers or designee and specialists 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 Abbott 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.
Demonstrates a high level of written and verbal communication skills with internal and external customers.
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
A Bachelor’s degree from an accredited university or college or equivalent work experience as a CRA.
Superb understanding of all aspects of clinical research.
Minimum five years clinical research experience.
Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills.
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.
Your preferred qualifications and education:
Strong preference for prior clinical monitoring experience.
A general familiarity with cardiac, vascular, and/or neuromodulation technologies.
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
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