Clinical Research Associate II

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

📋 Description

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

• Provide information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

• Align, educate, and inspire site staff and principal investigators about trial objectives, protocols, and patient treatment principles.

• Conduct site evaluations, training, routine monitoring, and activities related to site closure.

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

• Develop and tailor site engagement strategies while tracking progress through CRM tools.

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

• Mentor and train junior Clinical Research Associates (CRAs).

• Engage in global or local task forces and initiatives.

• Perform ongoing risk assessments in collaboration with the Central Monitoring team.

• Address site risk signals and implement preventive and corrective action plans.

• Identify and evaluate potential investigators and clinical trial sites.

• Ensure data integrity, timely data submissions, and appropriate safety-event reporting.

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments in accordance with contract obligations.

⛳️ Requirements

• A relevant tertiary qualification in health-related fields (Medical, Scientific, Nursing) is preferred.

• At least 1 year of clinically related experience.

• Minimum of 6 months of clinical research monitoring experience with investigational drug or device trials.

• Understanding of risk-based monitoring, encompassing both onsite and offsite monitoring.

• Preferred knowledge of applicable therapeutic area indications.

• Capability to comprehend and apply scientific concepts to the conduct of clinical trials.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational capabilities.

• Ability to thrive in a dynamic environment with competing projects and deadlines.

• Advanced proficiency in utilizing technology, tools, and resources.

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

• Capacity to establish and leverage site relationships through engagement, motivation, and training.

• Critical thinking and sound judgment to resolve issues at clinical sites.

• Integrity that aligns with AbbVie’s code of business conduct and leadership values.

• Self-driven with a focus on timely, quality outcomes in a fast-paced setting.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Equal opportunity employer.

• Reasonable accommodations for applicants with disabilities.