Clinical Trial Coordinator: Study Ops & Compliance

Deciphera Pharmaceuticals, Inc.; Waltham (MA); On-site; USD 90,000 - 124,000; Full time

Benefits offered by this job

Annual bonus

Benefits package

Parental leave

Career growth

Job summary

Deciphera Pharmaceuticals, Inc. in the United States is seeking a Clinical Trial Associate to support the execution of clinical studies within our Clinical Operations team.

This role emphasizes collaboration, attention to detail, and adherence to regulatory standards. You will work both independently and with cross-functional study teams to ensure study components are delivered on time, within scope, and in compliance with ICH guidelines and GCP across global trials.

Qualifications

• Bachelor’s or Master’s degree with 1–3 years of experience in a pharmaceutical, biotech, CRO, or academic research setting.
• Working knowledge of ICH guidelines, GCP, and global clinical trial regulations.
• Ability to manage assigned study activities with guidance from senior team members.
• Strong organizational skills and attention to detail.

Responsibilities

• Coordinate cross-functional study team meetings, including preparing agendas and capturing meeting minutes.
• Support site start-up activities and ongoing study coordination efforts.
• Assist in managing external vendors as needed.
• Participate in Investigator Meetings and contribute as appropriate.
• Maintain and track essential study documentation, including regulatory documents such as 1572s in collaboration with Regulatory teams.
• Support Trial Master File (TMF) activities, including document filing and quality control checks.
• Assist with the creation, editing, and distribution of study materials (e.g., informed consent forms, manuals).
• Maintain study trackers, tools, and systems to support execution and compliance.
• Support sample management activities and basic study logistics.
• Contribute to the review and maintenance of study documents as needed.
• Ensure assigned activities align with quality standards and regulatory requirements.
• Collaborate with team members to identify when escalation or additional input is needed.

Skills

Organizational skills

Attention to detail

Written and verbal communication

Education

Bachelor’s or Master’s degree

Job description

Deciphera Pharmaceuticals, Inc. in the United States is seeking a Clinical Trial Associate to support the execution of clinical studies within our Clinical Operations team.

This role emphasizes collaboration, attention to detail, and adherence to regulatory standards. You will work both independently and with cross-functional study teams to ensure study components are delivered on time, within scope, and in compliance with ICH guidelines and GCP across global trials.