Abbott Sr. Clinical Research Associate in Burlington, Massachusetts
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.
The Senior Clinical Research Associate works independently with minimal 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 complex problems; considers alternative or new perspectives using existing tools and standard processes. 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; assists with writing reports and protocols. May also provide 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:
a.) Drafts study related materials such as: patient brochures, patient recruitment material, and presentations.
b.) Drafts protocol summary, annual report, and other study reports.
c.) Drafts informed consent documents and ensures all required elements are included.
d.) Develops for review draft Case Report Forms and associated edit logic.
e.) Assists with site nomination, qualification, and selection processes. Can function to lead calls with FCE management if required.
f.) Provides product/protocol specific support and training to internal and external clinical personnel.
g.) In consultation with study management, the assigned field clinical personnel and appropriate inhouse personnel, coordinates the start-up and maintenance of the clinical study sites.
h.) Coordinates and lead activities with study specific committees, vendor services, and core labs.
i.) Reviews and analyzes data and documents for accuracy and completeness. Can lead study team to clean and review data. Creates and processes data queries.
j.) Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits.
k.) Independently reviews site compliance and raises issues to study management. Can lead team meetings reviewing compliance concerns.
l.) Reviews and processes product complaints and adverse events as soon as they are reported.
m.) Drafts Serious Adverse Event or death narratives.
Serves as a liaison to field clinical and site personnel by responding to any protocol-related issues and escalating as appropriate.
Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
Applies general clinical research processes and regulatory knowledge to actively improve processes and efficiencies.
Mentors less experienced clinical team members.
Contributes to global process improvement teams.
Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates effectiveness and appropriateness.
Exercises independent judgment in planning, organizing, and performing work; monitors performance and reports status to manager.
Provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work
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 five years clinical research experience.
Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem solvingskills.
Able to interpret clinical data, meet deadlines and work effectively with all levels of employees.
Proficiency in Microsoft Office Suite and relevant clinical applications.
The ability to work independently when necessary.
The ability to exchange straightforward information, ask questions, and check for understanding.
Advanced degree preferred with an academic focus in natural science, nursing,bioengineering or a related academic field.
An excellent understanding of all aspects of clinical research. A generalfamiliarity with cardiac, vascular, and/or neuromodulation technologies.
Previous related experience in research within a clinical or corporate setting or relevantclinical experience in a clinical/hospital environment.
Certification as a Research Professional by Society of Clinical ResearchAssociates (SoCRA) or Association of Clinical Research Professionals (ACRP).
Work habits include organization, coordination of many tasks, accuracy, andattention 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 email@example.com