Study Start-Up Specialist

Jobtailor; Chicago (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

Jobtailor is seeking a Clinical Research Coordinator with oncology experience in the Chicago area to lead site activation and start-up efforts. You will be the primary contact for JIT and expedited activations, coordinating with TIME sites, sponsor teams, and IRB processes.

This role requires strong project management, FDA/GCPHIPAA knowledge, and excellent communication to build relationships with sites and CRO partners.

Qualifications

• Bachelor’s degree in science or health related field is required.
• 2+ years of experience working as a clinical research coordinator in oncology or for a pharmaceutical company/CRO.
• Deep understanding of study start-up and site activation.
• Knowledge of FDA regulations, GCP, and HIPAA compliance.
• Strong project management, organization, and communication skills.
• Ability to develop relationships with sites and sponsors.
• CCRC preferable.
• Proficient in MS Office (Outlook, Word, Excel, PowerPoint).

Responsibilities

• Act as the single point of contact for JIT and expedited site activations, including maintaining activation timelines and answering start-up questions.
• Coordinate with TIME sites and sponsor teams to activate trials to enroll eligible patients.
• Collaborate with central IRB team to facilitate IRB review and approval.
• Attend bi-weekly meetings with the central IRB team and standing sponsor meetings.
• Educate TIME sites and sponsor partners on activation processes and best practices.
• Develop and implement new products, services, and workflows to drive efficiencies in SSU and TIME teams.
• Support feasibility and activation activities and prepare marketing collateral for TIME program.
• Handle administrative tasks associated with above activities.

Job description

• 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)