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 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, Highline Sciences 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 Highline Values:

Consistently strives to demonstrate the following Highline Sciences 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 Highline Sciences 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

Our core belief is that it’s all about the team.

More specifically, bringing great people together to deliver incredible outcomes. With this approach, we are a more flexible, collaborative, innovative, inspiring and successful organization. We also happen to have a lot of fun.

We believe in questioning the norm and looking for alternatives. We seek out team members who are driven by curiosity and understand the power of the collective. We encourage continual learning and constructive feedback. We strive to build and maintain trust, both internally and externally.

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