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Clinical Operations Project Coordinator II

2 months ago

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

Greetings,

My name is Gaurav, and I represent Net2Source Inc. Our esteemed client is in search of a Clinical Project Assistant II to enhance their dynamic team.

Position Title: Clinical Project Assistant II

FUNCTION: Clinical Operations – Biomarker and Bioanalytical Operations

POSITION SUMMARY:

The Clinical Operations department is tasked with the global execution of all Phase I - IV clinical trials across various therapeutic domains. This department plays a pivotal role in ensuring that all clinical trials adhere to relevant SOPs, corporate policies, and regulatory standards, thereby delivering timely and high-quality clinical data that supports the global registration and commercialization of products.

In this role, you will assist fellow team members in the Biomarker and Bioanalytical Operations with the initiation, management, and conclusion of clinical studies. Your responsibilities will include tracking and preparing study-specific data, reviewing and engaging in the quality assurance of data and documents, organizing meetings and their logistics, and aiding in the creation of documents and standard forms.

KEY RESPONSIBILITIES:

  • Track and prepare study-specific information utilizing databases, spreadsheets, and various tools.
  • Review and contribute to the quality assurance of data or documents.
  • Coordinate meeting logistics, agendas, and assist with the documentation of minutes.
  • Collaborate with other departments as necessary to fulfill assigned tasks.
  • Assist in the development of documents and standard forms.
  • Ensure compliance of your work with established practices, policies, processes, and any regulatory requirements.
  • Engage with cross-functional team members across therapeutic areas such as Oncology, Inflammation, and Virology.
  • Support sample reconciliation for ongoing clinical studies in collaboration with BBOps Study leads.
  • Participate in oral presentations as required.

QUALIFICATIONS:

We recognize that each individual brings unique contributions to serve patients. Below are the qualifications and skills we seek for this position:

  • MA/MS/PharmD/PhD with relevant clinical or related experience in life sciences.
  • BA/BS/RN with a minimum of 1 year of relevant work experience.
  • Preferred general clinical or business knowledge and experience.
  • Proficient in Word, PowerPoint, and Excel.
  • Exceptional verbal, written, interpersonal, and presentation skills are essential.

ADDITIONAL REQUIREMENTS:

  • Proven ability to learn quickly.
  • Flexibility and adaptability to change, with the capacity to transition between projects seamlessly.
  • Aptitude for understanding Gilead's business and the biopharma sector.
  • Strong teamwork and collaboration skills.
  • Excellent analytical and organizational abilities.
  • Familiarity with FDA, EMA, and other relevant national regulations, ICH guidelines, and GCP is preferred.
  • Proficient in using basic office programs and tools.
  • Ability to communicate clearly and concisely.
  • Capability to thrive in a team-oriented, highly matrixed environment.
  • Ability to manage multiple tasks as assigned.
  • Willingness to travel when necessary.

Thank you,

Gaurav Gupta

Sr. Pharma Recruiter