In-House Clinical Research Associates (ICRA) Assistant Manager

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. 

Our location in Sylmar, CA OR (Santa Clara, CA, Plano , TX, Maple Grove, MN) has an opportunity for an In-House Clinical Research Associates (ICRA) Assistant Manager. The CRA Assistant Manager is responsible for the supervision of a team of In-House Clinical Research Associates (ICRAs). Assists management in hiring, training, developing, and retaining qualified Site ICRAs. Also responsible for continuous, territory-based site resource allocation and management.  In addition, this position supports the start-up, conduct and closure of Abbott clinical studies, working independently with minimal guidance, direction and ensuring 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 leading site management activities such as collection of essential documents, site activations, and audit readiness activities.

WHAT YOU’LL DO

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

• Acts as a Business Unit champion for assigned therapeutic areas and clinical projects.

• Provides both managerial and individual level support and collaboration between Project Management, Data Review, Contracts, Payments, Safety, Field Personnel, and Investigational Sites.

• Supports career development of team members as well as creation and maintenance of talent profile, Goals and Objectives planning

• Acts as a direct resource to team members to address day-to-day, role specific questions and concerns

• Partners with management and HR Business Partner to address personnel issues as appropriate

• Attends recurring and ad-hoc study team calls as representative for all Site ICRAs within assigned Business Unit.

• Collaborates and assists in data and document review efforts for accuracy and completeness.

• Serves as a liaison to site management and site personnel by responding to any protocol/study related issues; escalates as appropriate.

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

• Applies expertise in clinical research processes and regulatory knowledge to the clinical department goals and objectives and actively improves processes and efficiencies.

• Contributes to global/regional process improvement teams/task forces.

• Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates effectiveness and appropriateness.

• Provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work Instruction (DWIs).

• Act as a subject matter expert for internal clinical processes.

• Leads activities within the Site Operations group

• Conducts regular 1:1s and utilizes available tools to track metrics for assigned Site ICRAs

• Provides support and training to internal and external clinical personnel regarding a variety of processes.

• In partnership with Abbott assigned field staff and in-house personnel, coordinates the start-up, maintenance and close out of the assigned clinical study sites within specific Business Units and/or territories.

• Provides mentorship to a variety of clinical team members.

• Exercises independent judgment in planning, organizing, and performing work, monitors performance and reports status as necessary.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required         

• A bachelor’s degree

• Minimum 5 years clinical research experience.

• Proficiency in Microsoft Office Suite and relevant clinical applications.

• Experience and understanding of all aspects of clinical research. A general familiarity with cardiac, vascular, and/or neuromodulation technologies.

• Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.

Preferred

• Advanced degree preferred with an academic focus in natural science, nursing, bioengineering or a related academic field.

• Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).

• Experience in (line) management of a team of clinical research professionals

• Work habits include organization, coordination of many tasks, accuracy, and attention to detail.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives, and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.