Clinical Research Start-Up Associate I

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 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.