Clinical Affairs Specialist at Abbott Laboratories | JP | Rezi

Clinical Affairs Specialist at Abbott Laboratories

Clinical Affairs Specialist

Abbott Laboratories · JP

Yesterday

Clinical Affairs Specialist

Abbott Laboratories · JP

a day ago
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About the Role

Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Clinical Research. Requires capacity to apply skills/knowledge within the context of specific needs or requirements in site management, including oversight of contract CRAs and mentoring of less experienced CRAs.

Responsibilities

  • Oversees the monitoring, planning, and execution of clinical trials/research, and data collection activities.
  • Contributes to the implementation of clinical protocols.
  • Recruits clinical investigators and negotiates study costs with clinical sites.
  • Directs human clinical trials, pre- and post-marketing trials, PMS, and clinical research activities.
  • Monitors compliance with protocols, J-GCP, GPSP, and SOPs.
  • Manages and oversees contract/temporary CRAs to ensure study activities are executed in compliance with protocols, SOPs, regulations, and study timelines.
  • Provides day-to-day guidance, performance oversight, and workload management for contract/temporary CRAs, including issue escalation and resolution.
  • Mentors and supports junior and less experienced CRAs through coaching, training, and regular feedback.
  • Facilitates knowledge sharing and promotes best practices across the CRA team.
  • May participate in adverse event reporting and safety monitoring responsibilities.
  • May act as a consultant and liaison with clinical sites.

Requirements

  • Minimum 3 years of experience as a CRA in the healthcare sector.

Skills

  • Site management
  • Oversight of contract CRAs
  • Mentoring CRAs
  • Monitoring clinical trials
  • Planning clinical trials
  • Execution of clinical trials
  • Data collection activities
  • Clinical protocol implementation
  • Clinical investigator recruitment
  • Study cost negotiation
  • Directing clinical trials
  • Compliance monitoring
  • Protocol compliance
  • J-GCP compliance
  • GPSP compliance
  • SOP compliance
  • Contract CRA management
  • Temporary CRA management
  • Issue escalation
  • Issue resolution
  • Coaching
  • Training
  • Performance feedback
  • Knowledge sharing
  • Best practice promotion
  • Adverse event reporting
  • Safety monitoring
  • Consulting
  • Liaison with clinical sites

Experience Level

  • Experienced professional

Education Level

  • Bachelor’s degree or above

Benefits

  • Career development with an international company
  • Access to diverse opportunities
  • Company recognized as a great place to work in dozens of countries
  • Named one of the most admired companies in the world by Fortune
  • Recognized as one of the best big companies to work for
  • Recognized as a best place to work for diversity
  • Recognized as a best place to work for working mothers
  • Recognized as a best place to work for female executives
  • Recognized as a best place to work for scientists

About the Company

  • Abbott is a global healthcare leader, creating breakthrough science to improve people’s health.
  • We’re always looking towards the future, anticipating changes in medical science and technology.

Equal Opportunity

  • Abbott is an Equal Opportunity Employer, committed to employee diversity.