Clinical Research Associate

Job Description
As a Clinical Research Associate, your purpose is to enable AbbVie’s emergence as a world class R&D organization. The position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies.

Your responsibilities

• For assigned sites/study(s), ensure successful protocol level execution of Clinical Site Management deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, training and activation, and monitoring close out and visit reports. Anticipate and identify site issues that could affect timelines and develop alternative solutions.
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
• Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
• Responsible for mentoring CRAs for various aspects of work.
• May be responsible for being the country point of contact for CROs for an assigned study. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.

Qualifications
We want you to have:

• Bachelor or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) is preferred.
• Minimum 1-2 years site monitoring experience.
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
• Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
• Demonstrated proactive and positive team player.
• Strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
• Demonstrated business ethics and integrity
• Current in-depth knowledge and understanding of appropriate therapeutic areas and of regulations such as ICH/GCP Guidelines and local regulations.
• Excellent Danish and English language skills, both verbally and in writing.

Additional Information
Contact Information
For more details about this position, please contact: Liz Sheasby (Country Clinical Operations Manager, Nordics) at: [email protected].
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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