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Clinical Research Coordinator II

2 months ago

San Mateo, California, United States Net2Source Inc. Full time

Position Overview:

We are seeking a dedicated Clinical Project Assistant II to join our dynamic team at Net2Source Inc. This role is pivotal in supporting the execution of clinical trials across various therapeutic areas, ensuring compliance with established protocols and regulatory standards.

Key Responsibilities:

  • Assist in the initiation, management, and closure of clinical studies.
  • Compile and organize study-specific data utilizing databases and spreadsheets.
  • Engage in quality assurance processes for clinical data and documentation.
  • Coordinate meeting logistics, including agenda preparation and minute-taking.
  • Collaborate with cross-functional teams to facilitate project completion.
  • Support the development of essential documents and standard operating procedures.
  • Ensure adherence to regulatory requirements and internal policies.
  • Participate in sample reconciliation efforts for ongoing clinical studies.
  • Utilize eTMF/Veeva systems for documentation management.
  • Contribute to presentations as necessary.

Qualifications:

The ideal candidate will possess a strong educational background and relevant experience in life sciences:

  • Advanced degree (MA/MS/PharmD/PhD) with applicable clinical experience.
  • Bachelor's degree (BA/BS) or RN with a minimum of one year of relevant experience.
  • Familiarity with clinical operations and business practices is advantageous.
  • Proficient in Microsoft Office Suite (Word, PowerPoint, Excel).
  • Exceptional verbal and written communication skills.

Additional Skills:

  • Ability to quickly adapt and learn in a fast-paced environment.
  • Strong teamwork and collaboration skills.
  • Excellent analytical and organizational capabilities.
  • Knowledge of FDA, EMA regulations, ICH guidelines, and GCP is preferred.
  • Ability to manage multiple tasks effectively.
  • Willingness to travel as required.

We value the unique contributions of each team member and are committed to fostering a collaborative work environment.