Remote Clinical Trials Project Specialist

Yale Cancer Center; New Haven, Northern (CT, KY); Hybrid; USD 62,000 - 92,000; Full time

Job summary

Yale Cancer Center seeks a Clinical Trials Project Specialist to support clinical research project management and interdisciplinary efforts. The role ensures regulatory compliance across TMF systems, DSMB coordination, and data reporting for multisite trials within a large university-affiliated network.

Responsibilities include maintaining essential study documents, collaborating with investigators, and supporting in budget development and system management (Clinicaltrials.gov, CTMS, REDCap,

Qualifications

• Knowledge of ICH GCP guidelines and regulatory requirements.
• Ability to switch among several projects without adverse effects.
• Strong interpersonal, oral and written communication skills; excellent organizational abilities.

Responsibilities

• Manages processing, tracking, and filing of study documents and updates including adverse events and regulatory reports.
• Collaborates with investigators, study teams and project managers to maintain essential regulatory documents in the TMF.
• Coordinates DSMB operations, timelines, data collection, meetings, and action item follow-up.

Skills

GCP knowledge

Interpersonal skills

MS Office proficiency

Education

Bachelor’s degree in related field or equivalent combination of education and experience

Job description

Yale Cancer Center seeks a Clinical Trials Project Specialist to support clinical research project management and interdisciplinary efforts. The role ensures regulatory compliance across TMF systems, DSMB coordination, and data reporting for multisite trials within a large university-affiliated network.

Responsibilities include maintaining essential study documents, collaborating with investigators, and supporting in budget development and system management (Clinicaltrials.gov, CTMS, REDCap,