Clinical Documentation Specialist II

Katalyst Healthcares & Life Sciences • Livingston, NJ

210d

About The Position

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Requirements

• Bachelor's degree or international equivalent preferred.
• Minimum 2 years relevant industry experience in clinical document management or equivalent experience preferred.
• Demonstrates analytical and critical thinking skills.
• Excellent oral and written communication skills; ability to facilitate cross-functional team meetings.
• Demonstrates awareness of clinical documentation business procedures.
• Compliant to clinical documentation processes.
• Experienced in using Microsoft PowerPoint and Excel &/or Document Management Systems preferred.

Responsibilities

• Manage Phase I to IV study activities.
• Ensure the Master File is always inspection-ready and complies with ICH GCP guidelines.
• Regularly update and assist study teams to address issues related to key Master File health indicators, including the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials.

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree