Clinical Research Associate

2 weeks ago

Foster City, California, United States Integrated Resources, Inc ( IRI ) Full time

Position Title: Clinical Project Associate - Biomarker

Location: Not Specified

Duration: Contractual Role

Position Overview:

  • The Clinical Operations team is pivotal in managing the global execution of clinical trials across various therapeutic areas, ensuring adherence to established SOPs, corporate policies, and regulatory standards to deliver high-quality clinical data that supports the registration and commercialization of products.
  • In this role, you will assist fellow team members in the initiation, management, and conclusion of clinical studies. Responsibilities include tracking and compiling study-specific data, reviewing documents for quality assurance, coordinating meetings and logistics, and aiding in the creation of necessary documentation and standard forms.

Key Responsibilities:

  • Compile and maintain study-specific information utilizing databases, spreadsheets, and other tools.
  • Engage in the quality assurance process for data and documentation.
  • Coordinate meeting logistics, prepare agendas, and assist in documenting minutes.
  • Collaborate with various departments to fulfill assigned responsibilities.
  • Support the development of necessary documents and standard forms.
  • Ensure compliance with established practices, policies, and regulatory requirements in your work.
  • Collaborate with cross-functional teams across therapeutic areas including Oncology, Inflammation, and Virology.
  • Assist in sample reconciliation for ongoing clinical studies in partnership with study leads.
  • Familiarity with eTMF/Veeva systems and support for eTMF filing.
  • Participate in presentations as required.

Qualifications:

We value diverse backgrounds and unique contributions to patient care. The following qualifications and skills are sought for this position:

  • Advanced degree (MA/MS/PharmD/PhD) with relevant clinical or life sciences experience.
  • Bachelor's degree (BA/BS) or RN with a minimum of one year of relevant experience.
  • General knowledge of clinical operations or business is advantageous.
  • Proficiency in Microsoft Word, PowerPoint, and Excel.
  • Strong verbal, written, and interpersonal communication skills are essential.

Additional Skills:

  • Ability to learn quickly and adapt to changing environments.
  • Flexibility to shift between projects and provide support where needed.
  • Understanding of the biopharma industry and the company’s operations.
  • Team-oriented mindset with a collaborative approach.
  • Strong analytical and organizational capabilities.
  • Familiarity with FDA, EMA regulations, ICH guidelines, and GCP is preferred.
  • Proficient in basic office software tools.
  • Clear and concise communication skills.
  • Ability to thrive in a team-oriented, matrixed environment.
  • Capability to manage multiple tasks effectively.
  • Willingness to travel as necessary.

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