• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Sr./Clinical Research Associate II (Unblinded)

Job Number: 34882

Location:

Job Description

The Clinical Research Associate supports clinical studies for product approvals and market adoption. Collaborating with cross-functional teams and vendors, they ensure trial success and quality results. They assist in establishing practices for future growth.

Responsibilities

  • Develop and maintain investigator relationships, ensuring protocol adherence and ICH-GCP compliance.
  • Facilitate scientific discussions on product and protocol requirements.
  • Monitor and resolve vendor issues, drive timelines, and train site staff.
  • Conduct site visits, administer training, and ensure data accuracy and compliance.
  • Manage device/medication accountability and regulatory submissions.
  • Protect subject rights, ensure data accuracy, and perform source data verification.
  • Communicate project updates and maintain compliance with regulations and company policies.
  • Demonstrate flexibility and initiative in completing assigned tasks.

Required Skills

  • Bachelor’s degree in a science field, Nursing degree preferred.
  • 3+ years of clinical trial monitoring experience, biotech/pharma background preferred.
  • Proficient in GCP, ICH guidelines, Microsoft Office.
  • Familiarity with clinical trial systems and terminology.
  • Strong organizational, problem-solving, time management skills.
  • Track record in dynamic environments, ability to lead projects and collaborate effectively.
  • Excellent communication skills, ethical standards.
  • Up to 25-50% travel required.

 

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