KEY DUTIES AND RESPONSIBILTIES 

• Act as the primary Sponsor point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening 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. 
• Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance, 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 customise site engagement strategy for assigned studies. 
• Gather local/site insights and utilise site engagement tools to report/track progress and measure impact of that strategy. 
• Connect 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’s disease journey. 
• Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. 
• Mentor and train less experienced CRAs on various aspects of work and provides input into their development.    
• Responsible for activities assigned by manager and participate in global/local task forces and initiatives. 
• Proactively responsible for continuous risk-assessment, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. 
• Resolves site risk signals while having a robust understanding of site processes to drive study execution, ensuring 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 ongoing basis 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. 
• Audit and regulatory inspection readiness at always assigned clinical site. 
• Manages investigator payments as per executed contract obligations, as applicable. 
• Report any adverse event within 24 hours as per AbbVie’s policies and procedures. 
• Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times. 
• Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity. 
• Other ad hoc duties such as administrative duties, as requested. 

Qualifications

• Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy). 
• 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.  
• Experience in Healthy Volunteer and First in Patient trials highly desirable
• Familiarity with risk‐based monitoring approach, onsite and offsite monitoring. 
• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders. 
• Demonstrate strong planning and organisational 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, 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 individuals focused on delivering timely and quality outcomes in a fast-paced environment. 
• Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials. 
• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. 
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KEY DUTIES AND RESPONSIBILTIES 

• Act as the primary Sponsor point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening 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. 
• Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance, 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 customise site engagement strategy for assigned studies. 
• Gather local/site insights and utilise site engagement tools to report/track progress and measure impact of that strategy. 
• Connect 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’s disease journey. 
• Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. 
• Mentor and train less experienced CRAs on various aspects of work and provides input into their development.    
• Responsible for activities assigned by manager and participate in global/local task forces and initiatives. 
• Proactively responsible for continuous risk-assessment, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. 
• Resolves site risk signals while having a robust understanding of site processes to drive study execution, ensuring 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 ongoing basis 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. 
• Audit and regulatory inspection readiness at always assigned clinical site. 
• Manages investigator payments as per executed contract obligations, as applicable. 
• Report any adverse event within 24 hours as per AbbVie’s policies and procedures. 
• Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times. 
• Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity. 
• Other ad hoc duties such as administrative duties, as requested. 

Qualifications

• Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy). 
• 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.  
• Experience in Healthy Volunteer and First in Patient trials highly desirable
• Familiarity with risk‐based monitoring approach, onsite and offsite monitoring. 
• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders. 
• Demonstrate strong planning and organisational 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, 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 individuals focused on delivering timely and quality outcomes in a fast-paced environment. 
• Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials. 
• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. 
•