Clinical Research Associate II – Immunology

This is a fully remote position, open to applicants in Louisiana, +2 more states.

📋 Description

• Act as the main point of contact for the investigation site.

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

• Align, train, and inspire site staff and principal investigators on the objectives of clinical trials, protocols, and principles of patient treatment.

• Carry out site assessments, training, regular monitoring, and closure activities.

• Ensure adherence to protocols, monitoring plans, regulations, Good Clinical Practices (GCPs), International Conference on Harmonisation (ICH) Guidelines, Standard Operating Procedures (SOPs), and quality standards.

• Create and tailor strategies for site engagement.

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

• Assist in the execution of clinical trials and ensure compliance with protocols.

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

• Develop knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys.

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

• Participate in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

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

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

• Ensure timely and accurate submission of data and reporting of safety events.

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments in accordance with contract obligations.

⛳️ Requirements

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

• At least 1 year of experience in a clinically related role.

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

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

• Preferred knowledge of relevant therapeutic area indications.

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

• Strong skills in cross-functional collaboration, planning, organization, interpersonal communication, writing, verbal communication, active listening, and presentations.

• Ability to utilize technology, tools, and resources effectively.

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

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

• Self-driven and capable of delivering high-quality outcomes in a fast-paced environment.

• Willingness to travel 75% of the time.

🏝️ Benefits

• Paid time off, including vacation, holidays, and sick leave.

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Travel compensation for roles requiring 75% travel.