Clinical Research Associate I (Start Up Focus)

Abbott; Alameda (CA); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Free HIP PPO medical plan

Excellent retirement savings plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Clinical Research Associate I (Start Up Focus) to support start-up activities at our Alameda, CA office. You will perform investigator debarment checks, collect regulatory documents, and prepare study files to enable efficient site initiation for ADC trials.

You will collaborate with cross-functional teams to ensure site qualification, trial master file integrity in Veeva Vault, and timely regulatory submissions while travel of 30-40% is expected.

Qualifications

• BS degree in life sciences with 1+ years of CRC/CTA experience preferred.
• Experience in conducting medical device studies preferred; pharmaceutical background may be considered.
• Demonstrated teamwork and strong interpersonal communication skills are valued.

Responsibilities

• Participate in study start-up activities including investigator debarment checks and regulatory document collection.
• Prepare study files and conduct Site Qualification Visits to ensure site readiness for ADC trials.
• Assist with shipment of study devices to clinical sites and coordinate with device group as needed.
• Maintain and audit Trial Master File and upload to Veeva Vault for inspection readiness.
• Proactively communicate trial status to management and support regulatory submissions.

Skills

CRC/CTA experience

GCP knowledge

Teamwork

Communication skills

Microsoft Excel

Education

BS degree in life sciences

Job description

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 122,000 colleagues serve people in more than 160 countries.

Clinical Research Associate I (Start Up Focus)

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as a best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Supports clinical trial start-up activities, including investigator debarment checks, regulatory document collection, study file preparation, site qualification visits, and site selection support.

This position will be based in our Alameda, CA office.

What You’ll Work On

• Participate in study start up activities, to include but not limited to, conducting investigator debarment checks, collection of regulatory documents and preparing the study files.
• Conduct Site Qualification Visits (SQV) and reporting to ensure study staff and research site are adequate to perform ADC trials.
• Assist with shipment of study devices and supplies to clinical sites and maintain communication with the device group as required.
• Responsible for assisting senior study startup staff during site selection
• Maintain and audit Trial Master File and upload to Veeva Vault to ensure inspection readiness.
• Proactively and effectively communicate the status of clinical trial start up to management.
• Support regulatory submissions
• Perform any other duties as assigned by management.
• Must be able to travel 30-40%

Required Qualifications

• BS degree in life sciences preferred, with 1+ years of experience as a CRC/CTA or combination of appropriate education and experience.
• Experience in conducting medical device studies preferred, pharmaceutical background may also be considered.
• Perform any other duties as assigned by management.

Preferred Qualifications

• Demonstrated excellence in teamwork, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
• Working knowledge of GCP, Clinical and Regulatory Affairs.
• Flexibility in daily activities.
• Proficient with Microsoft Suite

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.

Divisional Information

Medical Devices

General Medical Devices :

Our medical devices 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.

CRM

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.

Diabetes

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

Vascular

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

Neuromodulation

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Structural Heart

Structural Heart Business Mission : Why We Exist

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

EP

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

HF

In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

Diagnostics

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.

Nutrition

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

The base pay for this position is $73,900.00 – $116,000.00. In specific locations, the pay range may vary from the range posted.