Senior Clinical Research Associate – Site Excellence

BioSpace; Rome (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Life insurance

Medical plan

Company car

Flexible benefits

Job summary

AbbVie in the United States is seeking a Clinical Research Associate to advance our clinical trial program. You will partner with study teams, investigators and site staff to ensure trial conduct, data integrity and patient safety across sites.

You will train and motivate site staff, conduct monitoring visits, ensure regulatory compliance and contribute to risk assessment and site performance improvements. Strong collaboration and communication are essential.

Qualifications

• Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).
• Valid driver’s license.
• Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials.
• Familiar with risk-based monitoring approach, onsite and offsite monitoring.
• Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.

Responsibilities

• Partner with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements.
• Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
• Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance with the protocol and monitoring plans.
• Mentor and train less experienced CRAs on various aspects of work and provide input into their development.
• Identify, evaluate and recommend new/potential investigators/sites on an ongoing basis.

Skills

Cross-functional collaboration

Communication skills

Planning & organization

Site monitoring

Risk-based monitoring

Education

Bachelor's degree or equivalent

Job description

AbbVie in the United States is seeking a Clinical Research Associate to advance our clinical trial program. You will partner with study teams, investigators and site staff to ensure trial conduct, data integrity and patient safety across sites.

You will train and motivate site staff, conduct monitoring visits, ensure regulatory compliance and contribute to risk assessment and site performance improvements. Strong collaboration and communication are essential.