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Study Start-Up Specialist

Role overview

Qualifications

  • Bachelor’s degree in science or health related field
  • 2+ years of experience working as a clinical research coordinator in oncology or experience working for a pharmaceutical company/CRO
  • Deep understanding of study start-up and site activation
  • Knowledge of current FDA regulations, Good Clinical Practices governing clinical research, and HIPAA compliance

Responsibilities

  • Act as the single point of contact from Tempus for JIT and expedited site activations
  • Coordinate with TIME sites and sponsor teams to activate clinical trials
  • Collaborate with the central IRB team to facilitate IRB review and approval
  • Educate TIME sites and sponsor partners on the JIT and expedited activation processes and best practices

Key facts

Other skills

  • Microsoft Office
  • Communication
  • Problem Solving
  • Social Skills
  • Detail Oriented

About the company

Tempus logo

Tempus

Genomics & Precision Medicine

Tempus is making precision medicine a reality by applying AI in healthcare, deriving insights from our expansive library of clinical data and molecular data. We enable physicians to make real-time, data-driven decisions to deliver personalized care and targeted therapies for patients through our analytical machine learning platform that uses the power of artificial intelligence in healthcare. We also work with partners to facilitate discovery, development, and delivery of optimized therapeutic options for patients through distinctive solution sets. Our mission is for each patient to benefit from the treatment of others who came before by providing the healthcare industry tools that learn as we gather more data. It’s About Time. For more information, visit tempus.com and follow us on Twitter (@TempusLabs).

Company details

Company typeUnicorn
IndustryGenomics & Precision Medicine
Company size1001 - 5000

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Job description

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.

Responsibilities:

  • Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. 

  • Coordinate with TIME sites and sponsor teams to activate clinical trials through the JIT and expedited activation process in order to enroll eligible patients.

  • Collaborate with the central IRB team to facilitate IRB review and approval. 

    • Attend bi-weekly meetings with the central IRB team  

  • Educate TIME sites and sponsor partners on the JIT and expedited activation processes and best practices.

    • Attend Rapid Activation Demos for onboarding TIME sites 

    • Attend standing meetings with TIME sites to review site activation process and ongoing activations 

    • Attend sponsor KOMs (where applicable) 

    • Attend standing meetings with sponsors to review ongoing site activations (where applicable) 

  • Contribute to relationships with TIME sites and pharmaceutical/ CRO partners in the TIME program. 

  • Support the team performing feasibility, activations, and other activities within the start up processes.

  • Develop and implement new products, services, and workflows to drive efficiencies throughout the SSU and TIME team.

    • Contribute to the development of marketing collateral for the TIME program.

  • Administrative tasks associated with the activities listed above. 

Minimum Qualifications:

  • Bachelor’s degree in science or health related field.

  • 2+ years of experience working as a clinical research coordinator in oncology or  experience working for a pharmaceutical company/CRO.

  • Deep understanding of study start-up and site activation. 

  • Knowledge of current FDA regulations, Good Clinical Practices governing clinical research, and HIPAA compliance. 

  • Strong project management skills, with the ability to set goals and prioritize and manage multiple projects simultaneously.

  • Excellent organization and written/ oral communication skills with high attention to detail and accuracy.

  • Ability to develop and maintain strong relationships. 

  • Superior analytical, interpersonal, and problem-solving skills.

  • CCRC preferable

•• Proficient in the use of MS Office applications (Outlook, Word, Excel, PowerPoint).

#LI-DA1

$55,000-$70,000


The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

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. 

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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