AbbVie

Senior Clinical Research Associate

Employer
AbbVie
Location
Denver, Colorado
Posted
Jul 14, 2021
Ref
2110338
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.

  • Manage the daily operational activities in Puerto Rico of GPRD Phase I to IV clinical studies monitored by Abbvie in accordance with GCP/ICH guidelines and AbbVie SOPs.
  • Ensures clinical trial activities are conducted according to the monitoring plan and are in accordance with project timeliness and company objectives. Anticipates and identifies site issues that could affect timeliness and develops alternative solutions.
  • Assesses risk of issues raised by monitoring staff and understands their potential impact on operational and quality requirements and project timeliness. Elevates issues to appropriate AbbVie personnel and works to develop a resolution to reduce impact.
  • Serve as a contact for clinical sites personnel and SM&M for study related questions. Works with the Clinical Project Teams to establish GPRD clinical trials in Puerto Rico, while Identifies new potential sites in Puerto Rico and perform the feasibility work, investigators identification and sites evaluation.
  • Manage study start up activities that include essential documents preparation and collection and contracts and budgets negotiations. Local oversight of GPRD contractors.
  • Clinical project planning to include assessment of clinical development team headcount, resource planning, project timeliness and effective utilization of budget.
  • Effective communication of clinical projects related information including the planning and execution of meetings and presentations.
  • Act as a pharmacovigilance back-up for the Affiliate Safety Representative.

Qualifications
  • Bachelor's Degree required; medical/science/nursing background preferred. MS, MA, MBA, MPH desired.Minimum of 8 years clinical research experience, at least 1 year functioning in a lead capacity with mentoring/supervisory/leadership experience preferably in a country based capacity,At least 3 years experience in clinical site monitoring.Proven strong site management and monitoring skills. Relevant experience in multi-therapeutic areas desired. Good interpersonal skills.
  • Excellent communication skills and ability to work effectively across departments with corporate and regulatory agencies.Ability to effectively train and mentor others with less experience.Excellent verbal and written communication and presentation skills in both English and Spanish. Proficiency with appropriate computer programs.Must have an advanced and thorough knowledge related to ICH/GCP guidelines and/or federal regulations, and applicable local regulations.
  • Ability to work with multiple priorities in a work environment with frequent interruptions.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.