Clinical Trials Regulatory & Data Coordinator

Integrated Resources, Inc ( IRI ); Boston (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

A healthcare services provider in Boston is seeking a Regulatory Coordinator to ensure compliance for cancer trials. You will facilitate study activities, manage regulatory documents, and maintain communication with sponsors and investigators. Ideal candidates should have a BA/BS degree, certification in Human Subject Protections, and at least one year of experience in a research setting. This role is contract-based and offers an associate level position.

Qualifications

• Minimum of one year of experience in a research setting.
• Human Subject Protections Certification required.
• GCP Certification required.

Responsibilities

• Schedule and facilitate pre-activation activities for studies.
• Complete feasibility questionnaires for upcoming studies.
• Assist in start-up and implementation activities for new studies.
• Complete and submit clinical trials amendments to the IRB.
• Correspond with the IRB, investigators, and sponsors during trials.
• Prepare annual progress reports for IRB renewal.
• Manage data collection and submission of regulatory documents.
• Resolve data discrepancies as requested by Sponsors.

Skills

Regulatory compliance

Data management

Communication

Education

BA/BS required

Job description

A healthcare services provider in Boston is seeking a Regulatory Coordinator to ensure compliance for cancer trials. You will facilitate study activities, manage regulatory documents, and maintain communication with sponsors and investigators. Ideal candidates should have a BA/BS degree, certification in Human Subject Protections, and at least one year of experience in a research setting. This role is contract-based and offers an associate level position.