Senior Clinical Research Associate

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

📋 Description

• Acts as the Primary Sponsor Point of contact for the investigative site.

• Possesses advanced competency or experience in providing contextual insights on clinical trials, linking stakeholders to investigative sites, and enhancing AbbVie’s presence.

• Capable of inspiring and aligning the monitoring community through effective leadership and mentorship.

• Trains, aligns, and motivates site staff and principal investigators on the objectives of the clinical trial program, protocol, and principles of patient treatment, ensuring a reliable partnership.

• Provides support, guidance, and mentorship to junior personnel on Site Management activities.

• Conducts site evaluations, training, routine on-site and off-site monitoring, and closure activities, ensuring compliance with protocols and monitoring plans as well as applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards to safeguard study subjects.

• Exhibits a profound understanding of site engagement and the ability to tailor engagement strategies for assigned studies while critically assessing new strategies as necessary.

• Collects local/site insights and utilizes engagement tools to track progress and evaluate the impact of strategies employed.

• Demonstrates a high level of competency in connecting study protocols, scientific principles, and clinical trial requirements to daily execution activities.

• Possesses expert knowledge in developing effective recruitment and retention strategies based on the patient disease journey.

• Acquires in-depth knowledge of therapeutic areas, assets, and the clinical landscape/patient journey to facilitate successful patient recruitment and adherence to protocols.

• Holds advanced competency to mentor and train less experienced CRAs on various job aspects and contributes to their development.

• Aids in the local onboarding process for junior CRAs.

• Shows the ability to actively listen and consider different viewpoints to achieve better outcomes.

• May engage in or lead global/local task forces and initiatives.

• Responsible for tasks assigned by the manager.

• Conducts continuous risk assessments proactively and collaborates with the Central Monitoring team to oversee activities performed by clinical sites, identifying early study performance or patient safety concerns.

• Exhibits strong critical thinking skills to address site risk signals while maintaining a thorough understanding of site processes to facilitate study execution.

• Implements preventative and corrective action plans as necessary to mitigate risks and enhance compliance.

• Independently identifies, evaluates, and recommends new/potential investigators/sites continuously, demonstrating expert understanding and sound decision-making.

• Potential sites may be discovered through networking or internal AbbVie inquiries to assist in the placement of planned clinical studies with qualified investigators.

• Ensures the quality of data submitted from study sites and guarantees timely data submission, including proper reporting and follow-up for all safety events by site personnel.

• Maintains audit and regulatory inspection readiness at assigned clinical sites at all times.

• Manages investigator payments according to executed contract obligations, as applicable.

⛳️ Requirements

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

• Minimum of 3 years of clinically relevant experience, with at least 2 years preferably in independent clinical research monitoring of investigational drug or device trials across any therapeutic area.

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

• Understanding of relevant therapeutic area indications and the capability to interpret scientific concepts as they pertain to clinical trial conduct.

• Comprehensive knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Proven advanced communication and superior cross-functional collaboration skills with internal and external stakeholders.

• Demonstrates exceptional planning and organizational skills and the ability to work effectively in a dynamic environment with competing projects and deadlines.

• Strong ability to utilize technology, tools, and resources to provide customer-centric support based on site health.

• Excellent interpersonal skills with strong written, verbal, active listening, and presentation abilities, capable of establishing and leveraging site relationships and trusted partnerships through engagement, motivation, and training.

• Ability to independently apply functional expertise, leverage critical thinking, and exercise good judgment to resolve clinical site issues.

• Acts with integrity in alignment with AbbVie’s code of business conduct and leadership values.

• Self-driven individual focused on delivering timely and high-quality results in a fast-paced environment.

🏝️ Benefits

• Equal Opportunity Employer/Veterans/Disabled

• Commitment to operating with integrity

• Driving innovation

• Transforming lives