1+ months

Clinical Research Associate I

Burlington, MA

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.

Position Summary:

Working under direct supervision, 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. Performs routine assignments in this entry level position. Uses existing procedures to solve routine or standard problems. 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 also contribute to the development of study related materials.

Essential Functions:

1. Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical

projects. This may include but is not limited to:

a.) Assists in the development of study related materials such as: patient brochures, patient

recruitment material, and presentations.

b.) Assists in writing sections of the protocol summary, annual report, and other study reports.

c.) Assists in the development and review of informed consent document to ensure all required

elements are included.

d.) In consultation with the assigned field clinical and appropriate in-house personnel, coordinates

the start-up and maintenance of the clinical study site.

e.) Reviews and analyzes data and documents for accuracy and completeness. Creates and processes

data queries.

f.) Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits.

g.) Reviews and processes product complaints and adverse events as soon as they are reported.

2. 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.

a. Ensures the clinical study site adheres to the assigned protocol and all applicable regulatory

standards. Notify appropriate study management when concerns exist.

3. Communicates and collaborates with all levels of employees, customers, contractors, and vendors.

4. Applies general clinical research processes and regulatory knowledge to process improvement



Required: 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.

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.

The ability to generally work independently, but seek guidance when necessary.

The ability to exchange straightforward information, ask questions, and check for



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.
Job Family: Research and Discovery
Division: MD Medical Devices
Travel: Yes, 5 % of the Time
Medical Surveillance: Not Applicable
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


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Clinical Research Associate I

Burlington, MA

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