Remote CRA II – Oncology & Ophthalmology Monitoring

Syneos Health/ inVentiv Health Commercial LLC

North Dakota

Remote

USD 80,000 - 100,000

Full time

14 days+

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Job summary

Syneos Health is seeking a CRA II for Oncology/Ophthalmology to join a home-based role covering the Midwestern Region. The candidate will monitor sites, ensure patient safety, and maintain regulatory compliance across trials, with remote and on-site activities as needed.

The role requires knowledge of GCP/ICH guidelines, excellent communication, and strong collaboration with sponsors and investigative sites.

Qualifications

  • Bachelor's degree or RN in a related field; equivalent combination of education and experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
  • Strong computer skills and ability to embrace new technologies.
  • Excellent communication, presentation and interpersonal skills.

Responsibilities

  • Performs site qualification, initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and GPP compliance.
  • Verifies informed consent and protects subject confidentiality; assesses factors affecting subject safety and data integrity.
  • Reviews ISF and TMF, supports audit readiness and prepares for Investigator Meetings and sponsor meetings.
  • Applies data query resolution remotely and on-site to ensure timely data closure; manages documentation per SOPs.
  • May manage IP inventory, labeling, storage, and distribution following protocol requirements.
  • Maintains knowledge of ICH/GCP guidelines and company SOPs; provides training and site support throughout the study lifecycle.

Skills

Good computer skills
Excellent communication
Interpersonal skills
75% travel

Education

Bachelor's degree or RN

Job description

Syneos Health is seeking a CRA II for Oncology/Ophthalmology to join a home-based role covering the Midwestern Region. The candidate will monitor sites, ensure patient safety, and maintain regulatory compliance across trials, with remote and on-site activities as needed.

The role requires knowledge of GCP/ICH guidelines, excellent communication, and strong collaboration with sponsors and investigative sites.

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