Clinical Research Associate I (Start Up Focus)

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

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Diversity-friendly employer

Job summary

Abbott, a global healthcare leader, is seeking a Clinical Research Associate I (Start Up Focus) to support clinical trial start-up activities in Alameda, CA. You will assist with site qualification visits, regulatory document collection, and study file preparation.

The role requires a BS in life sciences with 1+ years of CRC/CTA experience; travel 30–40% is expected, and collaboration across teams is essential.

Qualifications

• BS degree in life sciences preferred with 1+ years of CRC/CTA experience.
• Experience in conducting medical device studies preferred; pharma background may also be considered.

Responsibilities

• Participate in study start-up activities including investigator debarment checks and regulatory document collection.
• Conduct Site Qualification Visits (SQV) and report to ensure study staff and site adequacy.
• Assist with shipment of study devices and supplies to clinical sites and communicate with device group.
• Support senior startup staff during site selection and maintain Trial Master File in Veeva Vault.
• Proactively communicate startup status to management and support regulatory submissions.
• Perform other duties as assigned and travel 30–40%.

Skills

Teamwork

GCP knowledge

Microsoft Suite

Flexibility

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.

JOB DESCRIPTION: 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 one of the 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.

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

Medical & Scientific Affairs

DIVISION

ADC Diabetes Care

LOCATION

United States > Alameda : Plaza 6 Building

WORK SHIFT

Standard

TRAVEL

Yes, 25 % 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)

EEO Statement

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. Abbott is an Equal Opportunity Employer, committed to employee diversity.

About Abbott

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best livesthrough better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in the workforce.