Clinical Research Associate II
AbbVie
20 days ago
On-site
Boston, MA
$84,500 - $162,000 USD yearly
Clinical Research and Development
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging new advanced capabilities to drive industry-leading performance.
Responsibilities:
- Primary point of contact for the investigative site; provide contextual information on clinical trials and strengthen AbbVie’s positioning.
- Align, train, and motivate site staff and the principal investigator on trial goals, protocol, and patient treatment principles.
- Conduct site evaluation, routine, and site closure monitoring with compliance to protocol/monitoring plans, regulations, GCPs, ICH guidelines, AbbVie SOPs, and quality standards to ensure subject safety and protection.
- Customize site engagement strategy for assigned studies; gather local/site insights and use CRM tools to track progress and measure impact.
- Connect protocol/scientific principles/clinical requirements to day-to-day execution; evaluate recruitment and retention techniques based on the patient disease journey; develop knowledge of therapeutic area/asset/clinical landscape to support recruitment and protocol compliance.
- Mentor and train less experienced CRAs; may participate in global/local task forces and initiatives.
- Proactively perform continuous risk assessment and partner with Central Monitoring to detect early study performance or patient safety issues.
- Resolve site risk signals; ensure preventive/corrective action plans are implemented using a customer-centric approach.
- Identify, evaluate, and recommend new investigators/sites.
- Ensure quality and timely submission of site data; ensure reporting/follow-up for safety events; maintain audit/regulatory inspection readiness; manage investigator payments per contract obligations.
Qualifications:
- Preferred tertiary qualification in Medical, Scientific, or Nursing.
- Minimum 1 year clinically related experience; includes 6 months in clinical research monitoring of investigational drug/device trials; familiar with risk-based monitoring and onsite/offsite monitoring.
- Preferred knowledge of therapeutic area indications.
- Advanced knowledge of local regulatory/legal requirements, ICH/GCP guidelines, and applicable policies.
- Strong cross-functional collaboration; planning/organizational skills; ability to work in a fast-paced environment.
- Advanced ability to leverage technology/tools for customer-centric site support.
- Strong interpersonal skills, written/verbal communication, active listening, and presentation skills.
- Ability to use functional expertise with good judgment to address clinical site issues.
- Acts with integrity consistent with AbbVie code and leadership values.
Responsibilities:
- Primary point of contact for the investigative site; provide contextual information on clinical trials and strengthen AbbVie’s positioning.
- Align, train, and motivate site staff and the principal investigator on trial goals, protocol, and patient treatment principles.
- Conduct site evaluation, routine, and site closure monitoring with compliance to protocol/monitoring plans, regulations, GCPs, ICH guidelines, AbbVie SOPs, and quality standards to ensure subject safety and protection.
- Customize site engagement strategy for assigned studies; gather local/site insights and use CRM tools to track progress and measure impact.
- Connect protocol/scientific principles/clinical requirements to day-to-day execution; evaluate recruitment and retention techniques based on the patient disease journey; develop knowledge of therapeutic area/asset/clinical landscape to support recruitment and protocol compliance.
- Mentor and train less experienced CRAs; may participate in global/local task forces and initiatives.
- Proactively perform continuous risk assessment and partner with Central Monitoring to detect early study performance or patient safety issues.
- Resolve site risk signals; ensure preventive/corrective action plans are implemented using a customer-centric approach.
- Identify, evaluate, and recommend new investigators/sites.
- Ensure quality and timely submission of site data; ensure reporting/follow-up for safety events; maintain audit/regulatory inspection readiness; manage investigator payments per contract obligations.
Qualifications:
- Preferred tertiary qualification in Medical, Scientific, or Nursing.
- Minimum 1 year clinically related experience; includes 6 months in clinical research monitoring of investigational drug/device trials; familiar with risk-based monitoring and onsite/offsite monitoring.
- Preferred knowledge of therapeutic area indications.
- Advanced knowledge of local regulatory/legal requirements, ICH/GCP guidelines, and applicable policies.
- Strong cross-functional collaboration; planning/organizational skills; ability to work in a fast-paced environment.
- Advanced ability to leverage technology/tools for customer-centric site support.
- Strong interpersonal skills, written/verbal communication, active listening, and presentation skills.
- Ability to use functional expertise with good judgment to address clinical site issues.
- Acts with integrity consistent with AbbVie code and leadership values.