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Summary:
Support the Clinical Trial Lead with the planning and implementation of clinical operations deliverables, primarily site management and clinical monitoring, of assigned project(s) to ensure delivery within specified budgets and timelines and in accordance with applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs) and project specific instructions.
Serves as Associate Clinical Trial Lead on complex studies, assisting the assigned Clinical Trial Lead with duties as assigned. This may include serving as the regional clinical lead for North America. Expected to build positive rapport with the internal and external project teams and site staff.
Job Responsibilities:
Working under the assigned Clinical Trial Lead, tasks may include but are not limited to:
Lead/Perform independently, with minimal guidance and oversight:
- Assists project team(s) with selective aspects of study management and site management from start-up to close-out
- Assists in tracking of site monitoring and monitoring visit report activities and metrics
- Assists in development of training materials and conducting training for the clinical operations team throughout the project lifecycle
- May be responsible for maintaining project specific training matrix
- Assist with the creation, QC, and review of project specific clinical operations plans, reference materials and tools
- Assist with review and analysis of clinical data, including data currency and quality
- Support creation of the Investigator Site Files (ISF) and/or Site Reference Manual as applicable
- May coordinate the distribution of clinical trial materials and ensure inventory is adequate for the overall study
- Support inspection ready TMF for duration of project(s); perform maintenance tasks such as filing and periodic quality reviews, assist with preparation for audits and archiving
- Contribute to and/or assist with maintenance of the Risk, Action, Issue and Decision (RAID) or Action, Issue and Decision (AID) tracker and the Risk Assessment Categorization Tool (RACT)
- Assist with maintaining and updating project-related data in the Clinical Trial Management System (CTMS), project specific SharePoint site(s) and/or other tracking spreadsheets as applicable
- Assist with project meeting agendas and/or minutes as assigned
- May conduct co-monitoring visits, assessment visits and/or team training, as necessary
- May conduct site evaluation, site initiation or site close-out visits as necessary and if adequately qualified and trained to perform the respective monitoring visit
- May be responsible for or assist with study level management of Clinical Research Associates (CRA meetings, performance oversight, visit planning, CRA training)
- May be responsible for reviewing and approving site monitoring visit reports
- May assist Regulatory Affairs and Investigation Services (RAIS) team with secondary review and QC of essential documents such as the Informed Consent or Clinical Trial Agreement
- May assist the Project Manager with processing of clinical investigator payments and other financial items
- Perform other duties as assigned
- May involve overnight travel
Demonstration of Compass Values:
Consistently strives to demonstrate the following 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:
- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
- Minimum of three (3) years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
- Minimum of one (1) year relevant clinical operations experience at a CRO, biotech or pharma company
- Oncology clinical trials or oncology clinical experience
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
- Demonstrated ability to build rapport with team members and clients
- Excellent written and verbal communication skills
- Excellent organization skills, attention to detail 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:
- Prior experience working for both a Sponsor company and a CRO
- Early phase clinical trial experience
- Prior experience working as a Clinical Research Associate or Site Management Associate
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The expected salary range below is applicable if the role is performed from [Illinois] and 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.
Additionally, for remote roles open to individuals in unincorporated Los Angeles – including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
