AbbVie

Senior Clinical Research Associate - Denver

Employer
AbbVie
Location
Denver, CO, United States
Posted
Sep 25, 2020
Ref
2007060
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

  • 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 1-4 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 onĀ­ 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 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring. 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.
  • 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.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Driving a personal auto or company car or truck, or a powered piece of material handling equipment
Travel
Yes, 50 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.