Clinical Operations Associate

2 weeks ago

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

Job Location: Remote

Job Duration: Contract

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

FUNCTION:
Clinical Operations – Biomarker and Bioanalytical Operations

Position Overview:

Clinical Operations is tasked with the global execution of all Phase I - IV clinical trials across various therapeutic areas. This department is crucial in ensuring that all clinical trials adhere to established 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 the Biomarker and Bioanalytical Operations team in the initiation, management, and closure of clinical studies. Your responsibilities will include tracking and preparing study-specific information, participating in the quality assurance of data and documents, coordinating 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.
  • Engage in the quality assurance process for data and 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 with established practices, policies, processes, and regulatory requirements.
  • Work alongside cross-functional team members in Oncology, Inflammation, and Virology therapeutic areas.
  • Support sample reconciliation for ongoing clinical studies in collaboration with study leads.
  • Utilize eTMF/Veeva systems 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 at least 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:
  • Ability to learn quickly and adapt to changing environments.
  • Flexibility to transition between projects and provide support where needed.
  • Teamwork and collaboration skills.
  • Strong analytical and organizational abilities.
  • Familiarity with FDA, EMA regulations, 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, matrixed environment.
  • Capability to manage multiple tasks as assigned.
  • Willingness to travel when necessary.

Job Type: Contract

Pay: $45.00 per hour

Work Location: Remote

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