Clinical Research Associate I
AbbVie
5 months ago
Remote friendly (Salt Lake City, UT)
United States
Clinical Research and Development
Remote/Field-based role. Candidates must live in the San Francisco or Los Angeles area and be willing to travel for site visits.
Responsibilities:
- Primary point of contact for investigative sites; provides trial context, connects stakeholders to sites, and strengthens AbbVie’s clinical trial positioning.
- Aligns, trains, and motivates site staff and the principal investigator on clinical trial program goals, protocol, and patient treatment principles.
- Conducts (under supervision) site evaluation, training, routine monitoring, and site closure monitoring in compliance with protocol/monitoring plans, applicable regulations, GCP, ICH guidelines, AbbVie SOPs, and quality standards to ensure subject safety and protection.
- Customizes site engagement strategy for assigned studies; gathers local site insights and uses tools such as CRM to track progress and measure impact.
- Applies study protocol/scientific principles to day-to-day execution; evaluates recruitment/retention strategies based on the patient disease journey; builds knowledge of therapeutic area/asset/clinical landscape to support recruitment and protocol compliance.
- Performs proactive continuous risk assessment and, with Central Monitoring, monitors site activities to detect early study performance and/or patient safety issues; resolves site risk signals using critical thinking.
- Ensures preventative and corrective action plans are implemented to mitigate risk and promote compliance using a customer-centric approach.
- Identifies, evaluates, and recommends new/potential investigators/sites (under supervision).
- Ensures quality and timely submission of site data, including appropriate safety reporting and follow-up.
- Maintains audit and regulatory inspection readiness; manages investigator payments per contract.
Qualifications:
- Tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred or equivalent experience.
- Clinically related experience, preferably in clinical research coordination or data management.
- Preferred knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trial conduct.
- Knowledge of local regulatory/legal requirements and ICH/GCP guidelines.
- Ability to collaborate cross-functionally; strong planning/organizational skills; effective in a fast-paced environment with competing deadlines.
- Ability to leverage technology/tools to provide customer-centric support; apply critical thinking and good judgment to address site issues.
- Strong interpersonal skills and written/verbal communication, active listening, and presentation skills; ability to build trusted site relationships through engagement, motivation, and training.
- Acts with integrity per AbbVie leadership values; self-motivated.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for short-term incentive programs.
Responsibilities:
- Primary point of contact for investigative sites; provides trial context, connects stakeholders to sites, and strengthens AbbVie’s clinical trial positioning.
- Aligns, trains, and motivates site staff and the principal investigator on clinical trial program goals, protocol, and patient treatment principles.
- Conducts (under supervision) site evaluation, training, routine monitoring, and site closure monitoring in compliance with protocol/monitoring plans, applicable regulations, GCP, ICH guidelines, AbbVie SOPs, and quality standards to ensure subject safety and protection.
- Customizes site engagement strategy for assigned studies; gathers local site insights and uses tools such as CRM to track progress and measure impact.
- Applies study protocol/scientific principles to day-to-day execution; evaluates recruitment/retention strategies based on the patient disease journey; builds knowledge of therapeutic area/asset/clinical landscape to support recruitment and protocol compliance.
- Performs proactive continuous risk assessment and, with Central Monitoring, monitors site activities to detect early study performance and/or patient safety issues; resolves site risk signals using critical thinking.
- Ensures preventative and corrective action plans are implemented to mitigate risk and promote compliance using a customer-centric approach.
- Identifies, evaluates, and recommends new/potential investigators/sites (under supervision).
- Ensures quality and timely submission of site data, including appropriate safety reporting and follow-up.
- Maintains audit and regulatory inspection readiness; manages investigator payments per contract.
Qualifications:
- Tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred or equivalent experience.
- Clinically related experience, preferably in clinical research coordination or data management.
- Preferred knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trial conduct.
- Knowledge of local regulatory/legal requirements and ICH/GCP guidelines.
- Ability to collaborate cross-functionally; strong planning/organizational skills; effective in a fast-paced environment with competing deadlines.
- Ability to leverage technology/tools to provide customer-centric support; apply critical thinking and good judgment to address site issues.
- Strong interpersonal skills and written/verbal communication, active listening, and presentation skills; ability to build trusted site relationships through engagement, motivation, and training.
- Acts with integrity per AbbVie leadership values; self-motivated.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for short-term incentive programs.