Note: The job is a remote job and is open to candidates in USA. AbbVie is a global biopharmaceutical company focused on discovering and delivering innovative medicines in key therapeutic areas including immunology. The Clinical Research Associate II role involves partnering with investigative sites to ensure the proper conduct of clinical trials, improving data integrity, compliance, and overall study performance. The position requires site engagement, training, monitoring, risk assessment, and ensuring regulatory compliance to advance AbbVie's clinical research pipeline.
Responsibilities
- Considered as the primary point of contact for the investigative site. High level of competency or experience in providing 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 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 with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects
- Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). 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
- Advanced 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
- Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager
- 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
- Advanced 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 on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators
- 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
Skills
- Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials
- Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Demonstrate strong cross-functional collaboration skills among internal and external stakeholders
- Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site
- Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training
- Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues
- 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
- Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing)
- Knowledge of appropriate therapeutic area indications
- Familiar with risk‐based monitoring approach, onsite and offsite monitoring
Benefits
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k) to eligible employees
- Eligible to participate in our short-term incentive programs
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