Project Coordinator

Highline Sciences is a specialized, full-service CRO and consultancy founded from within an oncology biotech to provide a better solution for innovative biotech companies. We are purposefully a different type of CRO. We aim to recruit, develop, and retain industry super stars that are curious, passionate, and want to make a difference. We’re looking for people who share our vision and want to contribute their unique skills and experience to a shared mission.

Support the Project Management team with overall cross-functional activities of assigned project(s) and project team(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 Project Coordinator on local or global complex oncology studies, assisting the Project Manager, with duties as assigned. Expected to build positive rapport with the internal and external project teams.

Job Responsibilities:

Working under the assigned Project Manager, tasks may include but are not limited to: 

• Assist project team(s) with selective aspects of study management from start-up to close-out
• Assist with project meetings including creation and maintenance of agendas, recording and documenting minutes, actions, decisions, and issues.  
• Assist with Risk Management inclusive of the Risk Assessment Categorization Tool (RACT)
• Maintain and update project-related systems such as the project specific SharePoint site(s) and/or other tracking mechanisms as applicable
• Maintain project specific training matrix and ensure the administration of training materials via the Tempus Compass Learning Management System (LMS)
• Assist with creation, QC, and review of project specific plans, reference materials and tools
• Engage with cross-functional teams and third parties/vendors to ensure effective teamwork and communication
• Support inspection ready TMF (Trial Master File) for duration of project(s); perform maintenance tasks such as filing and periodic quality reviews, support preparation for audits and project archiving
• Provide feedback on project team members’ performance to respective supervisors
• Contribute to project management initiatives
  

Demonstration of Tempus Compass Values:

Consistently strives to demonstrate the following Tempus 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 one (1) year relevant clinical research experience in a combination of research site, biotech, or pharma, or CRO (Contract Research Organization) experience
• Working knowledge of ICH (International Conference on Harmonization) Guidelines and GCP (Good Clinical Practice) 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 ability to handle multiple competing and changing priorities within tight timelines 
• Able to proactively anticipate needs and follow through on all assigned tasks 
• Proficient in MS Office, specifically  Word,  Excel, and PowerPoint
• Ability to travel overnight (up to 10%)