About this opportunity
Original employer descriptionAbbott 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 122,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
Main Purpose Of The Role
This role is based out of Sylmar, CA and is an ONSITE role.
The Senior Clinical Scientist works independently with minimal guidance and direction, assists in the planning and conduct of clinical studies. Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and 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.
Main Responsibilities
- Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include but is not limited to: Drafts study related materials such as: patient brochures, patient recruitment material, and presentations; Drafts protocol summary, annual report, and other study reports.; Drafts informed consent documents and ensures all required elements are included; Develops for review draft Case Report Forms and associated edit logic; Assists with site nomination, qualification, and selection processes. Can function to lead calls with FCE management if required. Provides conduct/protocol specific support and training to internal and external clinical personnel. 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. Coordinates and lead activities with study specific committees, vendor services, and core labs. Reviews and analyzes data and documents for accuracy and completeness. Can lead study team to clean and review data. Creates and processes data queries. Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits.
- Independently reviews site compliance and raises issues to study management. Can lead team meetings reviewing compliance concerns. Reviews and processes product complaints and adverse events as soon as they are reported. 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 Instruction (DWIs).
- Develops an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about division devices and therapies.
- Manages small projects and process improvement efforts that are critical to help support departmental goals and objectives.
- May participate in Core Team activities and make additional contributions as assigned.
Qualifications
Education:
- Bachelors Degree (± 16 years) in Natural science, pre-medicine, nursing, bioengineering, or a related academic field. OR an equivalent combination of education and work experience
- Masters Degree (± 18 years) preferred
Experience/Background
- Minimum 5 years in clinical or medical or research setting.
- Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem solving skills.
- 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.
- Preferred-An excellent understanding of all aspects of clinical research.
- A general familiarity with cardiac, vascular, and/or neuro modulation technologies.
- 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.
Apply Now
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$90,000.00 – $180,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Clinical Affairs / Statistics
DIVISION:
CRM Cardiac Rhythm Management
LOCATION:
United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
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), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
