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Senior Regulatory Operations Associate

Tempus

Tempus

Legal, Operations
Chicago, IL, USA
Posted on Thursday, June 6, 2024

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

The Senior Regulatory Operations Associate provides trial support to the Regulatory Operations team and Regulatory Affairs and Investigator Services department, thereby contributing to the overall management of clinical trials in accordance with applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs) and project specific plans.

Job Responsibilities:

  • Completes applicable protocol and disease indication training as needed.
  • Proactively and effectively drives site start up and maintenance activities.
  • Reviews essential documents for accuracy and completion.
  • Uploads documents to the Trial Master File (TMF).
  • Communicates directly with sites regarding site start-up or amendment activities, obtaining regular status updates and providing support to sites as needed.
  • Supports site feasibility activities, including distributing and receiving CDAs and feasibility questionnaires.
  • Maintains site tracking in Clinical Trial Management Systems (CTMS), as applicable for the lifetime of the study.
  • Provides regular updates to Manager/Sr. Manager, Regulatory Operations, and to internal study team as needed.
  • Completes distribution and applicable tracking of study Safety Reports to sites.
  • Participates in project-related meetings/teleconferences per the study team, as applicable.
  • Maintains close communication with the study team and assigned site staff.
  • Performs other duties as assigned.
  • May involve travel.

Demonstration of Tempus Compass Values:

Consistently strives to demonstrate the following Tempus Compass values:

  • Recognizes that the team is always stronger than the individual.
  • Seeks to inspire others by demonstrating consistently strong performance.
  • Treats people with respect regardless of role or point of view.
  • Listens well and seek to understand before reacting.
  • Provides candid, helpful and timely feedback to colleagues.
  • Demonstrates curiosity about and contributes effectively to areas outside of their specialty.
  • Keeps the bigger picture in mind when making decisions.
  • Never stops learning.
  • Questions assumptions and offers suggestions for improvement.
  • Focuses on results rather than process and seeks to minimize complexity when process is required.
  • Identifies and addresses root causes, not symptoms.
  • Demonstrates poise in stressful situations.
  • Strives to always do the right thing.
  • Questions actions that are incongruent with Tempus Compass values.

Minimum Qualifications:

  • High school/secondary level education required.
  • Minimum of 2+ years relevant clinical research experience at a research site, biotech or pharma, or CRO.
  • Working knowledge of ICH-GCP.
  • Excellent communication and interpersonal skills.
  • Excellent organizational skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines.
  • Able to proactively anticipate needs and follow through on all assigned tasks.
  • Proficient in Microsoft Word and Excel.

Preferred Qualifications:

  • Bachelor’s degree preferred.
  • 2+ or more years of previous related CRO or Pharma experience highly preferred.
  • Experience with CTMS or online databases

#LI-SH1 #LI-Remote

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.