JOB DESCRIPTION:Clinical Research Associate I The Opportunity The CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to the Code of Federal Regulations, ICH GCP, and ISO14155.
This is an on-site position in Alameda, California. This is not a remote position.
What You'll Work On- The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as assigned by management.
- Perform study site visits (SQV, SIV, IMV, COV), generate monitoring reports, and track resolution of action items.
- Assist and conduct clinical monitoring and site management activities, ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures, and other applicable regulatory requirements.
- Participate in study start up activities.
- Assist with shipping study devices and supplies to clinical sites.
- Perform study device accountability and reconciliation.
- Assist senior staff in development of study-specific forms and trial-specific monitoring plans.
- Assist senior staff in study planning, designing case report forms (CRFs), and training of study sites.
- Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection readiness.
- Perform review of clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager/Study Lead as needed.
- Proactively and effectively communicate the status of clinical studies to management.
- Participate in the interim and final reviews of study data in preparation of regulatory submissions.
- May interact with RA/QA in responding to audits and FDA inquiries.
- Perform any other duties as assigned by management.
- Must be able to travel 30-50%-, with additional travel as required.
Required Qualifications- BS degree in life sciences preferred or equivalent with minimum one (1) year of clinical research experience, or combination of appropriate education and experience.
Preferred Qualifications - Experience working on medical device studies and/or in-vitro diagnostics studies preferred. Pharmaceutical background may also be considered.
- Demonstrate excellence in teamwork, solid interpersonal and communication skills including building rapport with team members/peers, study site staff, and clinical management.
- Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs
- Proficient with Microsoft Suite
- 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
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Divisional InformationMedical 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.
JOB FAMILY:Research and Discovery
DIVISION:ADC Diabetes Care
LOCATION:United States > Alameda : Plaza 6 Building
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 10 % 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), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
