AbbVie

Clinical Research Associate II

AbbVie • $80K — $95K *
Edmonton, AB T5A 0A1In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Health-related tertiary qualification preferred (Medical, Scientific, Nursing)
  • Minimum of 2 years of monitoring experience in clinical settings
  • In-depth knowledge of therapeutic indications for clinical trials
  • Strong understanding of clinical research regulations, including ICH/GCP Guidelines
  • Familiarity with study monitoring aspects such as data and documentation
  • Excellent planning and organizational skills with the ability to navigate dynamic environments
  • Demonstrated integrity and strong interpersonal skills, capable of clear communication

Responsibilities

  • Monitor clinical investigative site activities to ensure protocol execution
  • Conduct site visits for qualification, initiation, monitoring, and closeout
  • Influence and motivate site personnel to meet study objectives
  • Ensure quality and timely data submission from study sites
  • Compliance oversight for the safety of study subjects
  • Train study site personnel on protocols and regulatory requirements
  • Manage investigator payments and negotiate agreements
  • Identify and evaluate potential investigators and sites for studies

Benefits

  • Comprehensive health benefits package
  • Opportunities for professional development and growth
  • Work in a dynamic, innovative R&D environment
  • Engagement with a world-class team of professionals
  • Flexibility in work arrangements to support travel requirements
Full Job Description
Job Description

To enable AbbVie' s emergence as a world class R&D organization, the position anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of Clinical Site Management deliverables involving start-up, execution, and close-out of studies.

Key Responsibilities:
  • Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures 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.
  • Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase I to III studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
  • Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
  • 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 safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
  • Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
  • Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
  • 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.


Qualifications
  • Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
  • Minimum of 2 years of clinically-related monitoring experience. Experience in on-site monitoring of investigational drug or device trials is required.
  • Current in-depth knowledge and understanding of appropriate 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 regulations.
  • Familiarity with all aspects of study monitoring; data, drug accountability, documentation experience.
  • Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
  • Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
  • Demonstrated business ethics and integrity.
  • A minimum of 50% travel is required.
  • Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.)
  • Must be at ease with technology (the use of various tools/systems to perform day-to-day tasks).
  • Travel required at least 50% of the time.
  • Valid driver's license and passport.


Additional Information

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

Stay Connected

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Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at AbbVie.

Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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