Clinical Research Associate II – Oncology

Research AnalystResearch AnalystFull TimeRemoteMid LevelTeam 10,001+Since 2013H1B SponsorCompany SiteLinkedIn

Location

California

Posted

2 days ago

Salary

$84.5K - $162K / year

Seniority

Mid Level

Postgraduate Degree1 yr expEnglishGoogle Cloud Platform

Job Description

Clinical Research Associate II – Oncology

AbbVie

• Advance AbbVie's pipeline by striving for excellence in clinical research. • Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the 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 point of contact for the investigative site. • High level of competency or experience in providing contextual information on the clinical trials. • Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans. • Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). • Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool. • Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. • Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. • Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. • Ensures preventative and corrective action plans are put into place as needed, to mitigate risk and promote compliance using a customer centric approach. • Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis.

Job Requirements

  • Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
  • Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials.
  • Familiar with risk‐based monitoring approach, onsite and offsite monitoring.
  • Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
  • Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
  • Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
  • Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
  • Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
  • Strong 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 use functional expertise with appropriate guidance, 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
  • eligible to participate in short-term incentive programs

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