Clinical Research Associate I/ Clinical Research Associate II

2 months ago
Full-time
Junior
Project and Program Management
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012

Description

  • Monitor and own the progress of clinical studies at investigative sites.
  • Ensure studies are conducted, recorded, and reported in accordance with protocol, SOPs, ICH-GCP, and applicable regulations and standards.
  • Coordinate study setup and monitoring activities, including identifying investigators and preparing regulatory submissions.
  • Conduct pre-study and initiation visits.
  • Manage study responsibilities across an average of one to two studies to maintain protocol expertise.
  • Identify potential study risks and propose mitigation solutions.
  • Support investigator meetings, site visits, and project team updates.
  • Handle issues and conflict using effective resolution strategies.
  • Provide input on study and project-related matters and contribute to positive change.

Requirements

  • University degree in life science, pharmacy, another health-related discipline, or equivalent experience in a scientific or healthcare discipline, or licensure as a health care professional.
  • At least 6 months of CRA experience in a CRO or pharmaceutical/biotech environment, or equivalent relevant experience and demonstrated competencies.
  • Site management experience or equivalent experience in clinical research.
  • Oncology monitoring experience.
  • Excellent communication and organizational skills.
  • Strong teamwork and client-focused approach.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Ability to travel overnight, with up to 60% travel on average and international travel as needed.
  • Fluency in English and Turkish.
  • Start-up activities experience is preferred.

Benefits

  • Fully home-based/remote position.
  • Reasonable travel expectations compared with many CRA roles.
  • Opportunity to focus on one to two studies and become a protocol expert.
  • Support from direct line management in a smaller CRO environment.
  • High CRA retention and a strong work-life balance culture.
  • Opportunity to have your voice heard and influence study decisions.
  • Employee contributions are appreciated and ideas are valued.

Interested in this position?

Apply directly on the company website

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