Clinical Trial Associate

Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’ scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit www.compasstherapeutics.com.

Our Clinical Operations team is seeking a highly motivated onsite Clinical Trial Associate. The ideal candidate will have a science background who desires to be part of an energetic, fast paced and collaborative team, where there is opportunity for career growth.

Responsibilities:

  • Support Director of Clinical Operations in overseeing CRO and vendors by tracking deliverables, metrics, and clinical milestones
  • Complete delegated daily clinical study activities for trial execution in compliance with applicable SOPs, protocols, ICH/GCP guidelines and other regulatory requirements
  • Assist in study management, including drafting and review of study documentation, including study plans, informed consent forms, system documentation, and other study related materials
  • Support the coordination and tracking of investigational drug supply shipments, site materials, and patient samples
  • Participate in collection, tracking, and maintenance of clinical trial documentation and regulatory documents for the Trial Master File (TMF)
  • Review vendor TMF documents for completeness, accuracy, and compliance with protocol, study plans, and applicable regulations; act as primary liaison with the CRO to ensure inspection readiness; identify issues and collaborate on resolution tasks
  • Support project meeting logistics such as: calendar management, room & equipment set up, collation of materials, and attendance tracking
  • Responsible for ad-hoc projects supporting department initiatives, as agreed with Director of Clinical Operations

Qualifications:

  • Bachelor’s degree or equivalent international degree, life/health sciences or healthcare related field preferred
  • Prior experience in drug development industry, clinical research organization, or related role preferred
  • Strong computer skills including knowledge of Excel, Word, PowerPoint, SharePoint, and Outlook
  • Ability to learn new computer systems
  • Experience supporting global/international studies or oncology indications is advantageous
  • Knowledge of global regulatory and compliance requirements for clinical research, or ability to learn fundamentals quickly
  • Able to interact and communicate professionally with vendors and colleagues at all levels of the organization
  • Self-motivated, collaborative, organized, flexible, and eager to try new things
  • Ability to work flexibly and balance multiple project objectives in a fast-paced, cross-functional, collaborative work environment

 

At Compass Therapeutics, we provide employees with an inclusive offering of benefits and a competitive compensation package. We offer our employees competitive salaries, discretionary bonuses and meaningful equity participation. Our benefits support the health and wellness of our employees; from medical, dental and vision benefits to health reimbursement arrangement, flexible spending accounts, sponsored gym membership, and an employee assistance program. We also provide company matched 401(k) and Roth 401(k) programs and other tools for financial wellness. Additional benefits include commuter reimbursement, subsidized parking, and substantial paid time off including a winter shut-down week.

We believe in growing and developing our team, and therefore, we invest in the development of strong values and culture. We are invested in employee success and provide tuition reimbursement, employee recognition programs and referral programs, training opportunities and maintain a comprehensive Performance Management cycle. While building a strong foundation, Compass culture can be seen every day in the form of curiosity, teamwork, passion, and cross functional collaboration.