Considered as the primary point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning
Aligns, trains and motivates the site staff and principal investigator under supervision on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership
Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects
Customize site engagement strategy for assigned study (ies) under supervision
Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy
Fundamental level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities
Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey
Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance
Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues
Ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution
Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach
Identifies, evaluates and recommends new/potential investigators/sites under supervision and support from more experienced CRAs
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
Ensures audit and regulatory inspection readiness at assigned clinical site at all times
Manages investigator payments as per executed contract obligations, as applicable

Requirements

Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred or experience or equivalent work experience
Clinically related experience, preferably in clinical research coordinating or data management
Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
Able to work collaboratively and cross functionally to develop and sustain working relationships
Demonstrate planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
Ability to leverage technology, tools and resources to provide customer centric support based on the health of the site
Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues
Interpersonal skills with strong written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training
Acts with integrity in accordance with AbbVie code of business conduct and leadership values
Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Benefits

paid time off (vacation, holidays, sick)
medical/dental/vision insurance
401(k) to eligible employees
participation in short-term incentive programs

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchdata managementsite evaluationsite trainingrisk assessmentpatient recruitmentprotocol complianceGood Clinical Practices (GCP)ICH Guidelinesscientific concepts

Soft Skills

collaborative workplanning skillsorganizational skillscritical thinkinginterpersonal skillscommunication skillsactive listeningpresentation skillsself-motivationintegrity