Clinical Operations Project Coordinator II

2 weeks ago

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

Greetings,

My name is Gaurav, and I represent Net2Source Inc. Our esteemed client is seeking to recruit a Clinical Project Assistant II to enhance their expanding 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 team plays a crucial role in ensuring that all clinical trials adhere to relevant SOPs, company 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 information, reviewing and contributing to the quality assurance of data and documents, coordinating meetings and their logistics, and aiding in the development of necessary documents and standard forms.

KEY RESPONSIBILITIES:

  • Track and prepare study-specific information utilizing databases, spreadsheets, and other tools.
  • Review and engage in the quality assurance of data or documents.
  • Coordinate meeting logistics, prepare agendas, and assist with minute-taking.
  • Collaborate with other departments as necessary to fulfill assigned tasks.
  • Assist in the creation of documents and standard forms.
  • Ensure compliance of your work with established practices, policies, processes, and regulatory requirements.
  • Collaborate with cross-functional team members across various therapeutic areas.
  • Support sample reconciliation for ongoing clinical studies in partnership with study leads on sample tracking.
  • Engage with eTMF/Veeva systems and assist with eTMF filing.
  • Participate in oral presentations as required.

QUALIFICATIONS:

We value diversity and recognize that each individual brings unique contributions to our mission. 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.
  • General clinical or business knowledge and experience is preferred.
  • 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 capability to transition between projects smoothly.
  • Aptitude for understanding the biopharma industry and the business of Gilead.
  • Strong teamwork and collaboration skills.
  • Good analytical and organizational abilities.
  • Familiarity with FDA, EMA, and other national regulations, as well as ICH guidelines and GCP is preferred.
  • Proficient in basic office programs and tools.
  • Clear and concise communication skills.
  • Ability to thrive in a team-oriented, highly matrixed environment.
  • Capability to manage multiple tasks as assigned.
  • Willingness to travel when necessary.

Thank you,

Gaurav Gupta

Sr. Pharma Recruiter

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