
Senior Clinical Research Associate
AbbVie
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $94,000 - $178,500 per year
Job Level
Tech Stack
About the role
- Advance AbbVie’s pipeline by striving for excellence in clinical research
- Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials
- Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience
- Considered as the Primary Sponsor Point of contact for the investigative site
- Advanced level of competency or experience in providing contextual information on the clinical trials
- Ability to motivate and align monitoring community through leadership and mentorship
- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program
- Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities
- Ensure safety and protection of study subjects
- Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy
- Ensures quality of data submitted from study sites and assures timely submission of data
- Manage investigator payments as per executed contract obligations, as applicable
Requirements
- Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy)
- Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area
- Familiar with risk‐based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
- Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders
- Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Superior ability to leverage technology, tools and resources to provide customer centric support based on the health of the site
- Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training
- Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k) to eligible employees
- short-term incentive programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchindependent clinical research monitoringrisk-based monitoringdata integritycompliancesite evaluationsite trainingmonitoring activitiesinvestigator paymentstherapeutic area knowledge
Soft Skills
leadershipmentorshipcommunicationcross-functional collaborationplanningorganizational skillscritical thinkingintegrityself-motivationcustomer centric support
Certifications
Bachelor's degreeICH/GCP Guidelines knowledge