Job Description

Job Description

Job Description

Hybrid Role

We are seeking an experienced Clinical Research Associate (CRA) to join our dynamic Clinical Operations team. The ideal candidate will have extensive and proven experience in site monitoring and developing effective recruitment and retention strategies. This role is critical to ensuring the successful execution of clinical trials and maintaining high standards of data integrity and patient safety.

Key Responsibilities:

• Site Monitoring:
  • Conduct regular site visits to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
  • Monitor patient recruitment, informed consent process, and adherence to study timelines.
  • Review and verify case report forms (CRFs) and source documents for accuracy and completeness.
  • Identify and resolve site-related issues and discrepancies.

• Recruitment and Retention Strategies:
  • Develop and implement effective patient recruitment and retention plans tailored to each study based on approved vendors.
  • Collaborate with site staff to identify potential recruitment barriers and develop solutions.
  • Track and report on recruitment and retention metrics, providing regular updates to the project team.
  • Engage with patients and site staff to ensure a positive study experience and address any concerns.

• Communication and Collaboration:
  • Serve as the primary point of contact for study sites, providing guidance and support as needed.
  • Collaborate with cross-functional teams, including project managers, data managers, and regulatory affairs.
  • Prepare and present study progress reports to internal and external stakeholders.

• Training and Development:
  • Train and mentor site staff on study protocols, GCP, and regulatory requirements.
  • Stay current with industry trends and best practices in clinical research and site management.

Qualifications:

• Bachelor's degree in life sciences, nursing, or a related field. Advanced degree preferred.
• Minimum of 3 years of experience as a site clinical research coordinator or CRA, with a focus on site monitoring and patient recruitment/retention.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to travel weekly.

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