Clinical Research Associate

AbbVie is seeking a Clinical Research Associate (CRA) to join our team in Israel. As part of AbbVies commitment to being a world-class R&D organization the Clinical Research Associate plays a key role in ensuring the successful delivery of clinical studies. The position proactively identifies and resolves study-related issues at clinical sites and supports the implementation of appropriate corrective actions throughout the study lifecycle including site start-up study conduct and close-out activities.

Responsibilities

• Monitor activities conducted by clinical investigative sites in support of AbbVie clinical studies to ensure the successful execution of study protocols.
• Ensure adherence to federal and applicable local regulations Good Clinical Practice (GCP) ICH Guidelines AbbVie Standard Operating Procedures (SOPs) monitoring plans and quality standards for the conduct of clinical research.
• Conduct site qualification initiation interim monitoring and study closeout visits for Phase 14 studies in accordance with applicable regulations GCP ICH Guidelines AbbVie SOPs and relevant business processes.
• Oversee the activities of site personnel despite having no direct authority and motivate and influence them to meet study objectives.
• Proactively manage assigned sites and ensure that appropriate action plans are implemented as needed to maintain compliance.
• Ensure regulatory inspection readiness at assigned clinical sites.
• Ensure the quality of data submitted by study sites and the timely submission of data including appropriate reporting and follow-up of all safety events by site personnel.
• Ensure the safety and protection of study subjects through compliance with the study monitoring plan AbbVie SOPs ICH Guidelines and applicable regulations.
• Train study site personnel on the study protocol and applicable regulatory requirements in collaboration with relevant project team members.
• Manage investigator payments in accordance with executed contractual obligations.
• Negotiate investigator and hospital agreements with relevant stakeholders.
• Maintain and complete expense reports in accordance with local and applicable guidelines.
• Identify evaluate and recommend new and potential investigators and clinical sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to support the placement of planned clinical studies with qualified investigators.

Qualifications :

• Appropriate tertiary qualification; a health-related degree or background such as Medicine Life Sciences or Nursing is preferred.
• Minimum of 1 to 2 years of experience as a CRA at a pharmaceutical company or CRO. Candidates with approximately 2 years of experience in clinical trials field particularly within oncology or immunology can be considered.
• Experience conducting on-site monitoring of investigational drug or medical device trials is required.
• Current in-depth knowledge and understanding of relevant therapeutic indications as they relate to the conduct of clinical trials.
• Current in-depth knowledge of regulations governing clinical research ICH/GCP Guidelines and applicable local regulations.
• Strong planning and organizational skills with the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Ability to understand and follow work processes within the assigned function.
• Strong analytical and conceptual capabilities interpersonal skills and the ability to communicate clearly.
• Ability to address clinical site issues with appropriate guidance initiate corrective actions and communicate them effectively.
• Ability to apply functional expertise and exercise sound judgment.
• Demonstrated business ethics and integrity.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Yes

Employment Type :

Full-time