Study Start-Up Specialist

Role Summary

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.

Requirements

• 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).
• $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.