Clinical Research Associate II

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Act as the main point of contact for investigative sites.

• Provide context for clinical trials and facilitate connections between stakeholders and investigative sites.

• Align, instruct, and inspire site personnel and principal investigators regarding trial objectives, protocols, and patient treatment principles.

• Perform site evaluations, training, routine monitoring, and closure activities.

• Ensure adherence to protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards.

• Develop and implement tailored site engagement strategies.

• Collect site insights and utilize CRM tools to monitor progress and assess impact.

• Assess recruitment and retention strategies based on the patient disease journey.

• Mentor and train less experienced Clinical Research Associates (CRAs).

• Engage in global and local task forces and initiatives.

• Carry out continuous risk assessments and collaborate with Central Monitoring to address study performance or patient safety concerns.

• Implement preventative and corrective action plans to mitigate risks and enhance compliance.

• Identify, assess, and recommend investigators and clinical trial sites.

• Guarantee quality and timely submission of site data and safety event reports.

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments as necessary.

⛳️ Requirements

• A minimum of 1 year of clinically related experience.

• At least 6 months of experience in clinical research monitoring for investigational drug or device trials.

• Familiarity with risk-based monitoring, both onsite and offsite.

• Preferred knowledge of relevant therapeutic area indications.

• Advanced understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and relevant policies.

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

• Capability to thrive in a dynamic environment with multiple projects and deadlines.

• Proficient in leveraging technology, tools, and resources to support sites.

• Strong interpersonal, written, verbal, active listening, and presentation skills.

• Ability to build site relationships and establish trusted partnerships.

• Capacity to apply critical thinking and sound judgment to clinical site challenges.

• Commitment to acting with integrity according to AbbVie’s code of business conduct and leadership values.

• Self-motivated and focused on achieving timely, quality outcomes.

• Preferred tertiary qualification in a health-related field (Medical, Scientific, Nursing).

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Remote work arrangement.