Clinical Trial Associate

2 weeks ago

Boston, United States Compass Therapeutics Full time
Job DescriptionJob Description

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. Our 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. We plan to advance our product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. We were founded in 2014 and are headquartered in Boston, Massachusetts. For more information, visit www.compasstherapeutics.com.

Our Clinical Operations team is seeking a hands-on Clinical Trial Associate, reporting to our reports onsite to our VP & Head of Clinical Operations. The ideal candidate will have a science background and desires to be part of a fast paced and collaborative team, where there is opportunity for career growth.

This position is fully in-person and reports onsite to our office in Brighton, MA.

Responsibilities:

  • Support the Clinical Operations team in overseeing CRO and vendors by tracking deliverables, metrics, and clinical milestones
  • Complete daily clinical study activities for trial execution in compliance with applicable SOPs, protocols, ICH/GCP guidelines and other regulatory requirements
  • Lead various tasks to directly support Clinical programs and general Clinical Department
  • Work with the team to maintain the collection, tracking, and maintenance of clinical trial documentation and regulatory documents for the Trial Master File (TMF)
  • Assist in study management, 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
  • Review vendor TMF documents for completeness, accuracy, and compliance with protocol, study plans, and applicable regulations; act as liaison with the CRO to ensure inspection readiness; identify issues and collaborate on a resolution
  • Effectively manage relationships with CROs, consultants, other external or internal stakeholders
  • 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

Qualifications:

  • Bachelor's degree (or equivalent international degree) in life/health sciences or healthcare related field is required, Master's degree is a plus
  • 2+ years of relevant experience in the drug development industry, clinical research organization, or related role preferred
  • Strong computer skills including expertise in Excel, Word, PowerPoint, SharePoint, and Outlook
  • Ability to learn new computer systems and platforms/portals utilized by clinical vendors
  • Experience supporting clinical studies or oncology indications is advantageous
  • Understanding 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, and eager to take on new tasks
  • Excellent task management, problem solving, written and verbal business communication skills
  • Ability to work flexibly and balance multiple project objectives in a fast-paced, cross-functional, collaborative work environment

At Compass, 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 innovative 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, an employee assistance program, life insurance, and much more. We also provide 401(k) and Roth 401(k) programs with a 6% company match, and other resources for financial wellness. Additional benefits include commuter reimbursement, subsidized company parking, cell phone reimbursement, Summer Fridays, and substantial paid time off including a winter shut down week.

Our Mission at Compass is to develop next generation antibodies into transformative cancer therapies that improve patients' lives. Our Compass Core Values guide us in achieving this. We are mission-focused and share a passion for science and creativity that help us innovate in all that we do. Our unique community promotes authenticity, diversity of thought, and collaborative teamwork.

We invest in the growth and development of our teams and individuals through programs such as company-wide trainings, cross-functional collaboration and job shadowing, tuition reimbursement, employee recognition awards, and a comprehensive performance management cycle. Also, our Compass Culture Committee empowers employee-organized events that celebrate wins, drive initiatives, support local philanthropy, and align with our mission and values.

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