Clinical Operations Associate

2 weeks ago

Foster City, California, United States Integrated Resources, Inc Full time
Job Title: Clinical Project Associate - II

Job Location: Not specified

Job Duration: 12 Months (Possible extension)

Pay Rate: $40 - $45/hour on W2

FUNCTION:
Clinical Operations – Biomarker and Bioanalytical Operations

Position Overview:

The Clinical Operations team is tasked with the global execution of all Phase I - IV clinical trials across various therapeutic areas. This team plays a pivotal role in ensuring that all clinical trials are conducted in compliance with established SOPs, corporate policies, and regulatory standards, thereby delivering timely and high-quality clinical data to support the global registration and commercialization of products.

In this role, you will assist fellow team members in the initiation, management, and conclusion of clinical studies. Your responsibilities will include tracking and preparing study-specific information, reviewing and ensuring the quality of data and documents, organizing meetings and logistics, and aiding in the development of necessary documentation and standard forms.


Key Responsibilities:
  • Track and prepare study-specific information utilizing databases, spreadsheets, and other tools.
  • Review and ensure the quality assurance of data or documents.
  • Coordinate meeting logistics, prepare agendas, and assist with minutes.
  • Collaborate with other departments as necessary to complete 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.
  • Utilize eTMF/Veeva system and assist with eTMF filing.
  • Participate in oral presentations as required.

Requirements:

We value diverse backgrounds and unique contributions to serve patients effectively. Below are the qualifications and skills we seek for this role:

  • 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.
  • Excellent verbal, written, interpersonal, and presentation skills are essential.

Knowledge & Other Requirements:
  • Proven ability to learn quickly.
  • Flexibility and adaptability to change, with the capacity to transition between projects seamlessly.
  • Aptitude for understanding the biopharma industry and the company's operations.
  • Strong teamwork and collaboration skills.
  • Good analytical and organizational abilities.
  • Familiarity with FDA, EMA, and other relevant regulations, as well as ICH guidelines and GCP is preferred.
  • Proficient in basic office software and tools.
  • Ability to communicate clearly and concisely.
  • Capacity to thrive in a team-oriented, highly matrixed environment.
  • Able to manage multiple tasks effectively.
  • Willingness to travel when necessary.

Job Type: Contract

Pay: $45.00 per hour

Work Location: In person

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