JOB DESCRIPTION:Clinical Research Associate IThe 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.
What You'll Work On- Perform internal clinical studies, recruit study participants, conduct informed consent discussions with study volunteers, record study data, and maintain study files.
- Coordinate internal clinical studies from start to close-out.
- 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.
Required Qualifications- BS degree in life sciences preferred or equivalent with minimum 2 years of as a CRA/CRC/CTA experience, or combination of appropriate education and experience.
- Experience in conducting medical device studies and/or in-vitro diagnostics studies preferred. Pharmaceutical background may also be considered.
- Perform any other duties as assigned by management.
- 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
- Flexibility in daily activities.
- Proficient with Microsoft Suite
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
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.
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.
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:No
MEDICAL SURVEILLANCE:No
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)
