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.
Study Start-Up Manager at Tempus
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.
3+ 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. JIT study start-up experience is a plus.
Knowledge of current FDA regulations, Good Clinical Practices (GCP's) governing clinical research, and HIPAA compliance.
Strong project management skills, with the ability to set goals and prioritize/manage multiple projects and tasks.
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
$90,000-$120,000
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.
Benefits
Health insuranceEquity / stock options
Additional Information
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.
Tempus created the TIME clinical trials network to increase patient access to clinical trials by bringing clinical trials to patients in the community setting. The TIME program is an industry leader in the field of just-in-time (JIT) clinical trials.
We are looking for an experienced Study Start-Up Manager who will work with our cross- functional team to manage study start-up and site activations for key research sites in the TIME research network. The TIME Program is fundamentally changing how patients access clinical trials, and we need energetic, creative, and patient-focused people to help us do that.
Tempus · Chicago