Clinical Research 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

Overview

POSITION SUMMARY: As a direct report to the Clinical Research Director, the Regulatory Coordinator works closely with research teams across the Department to ensure regulatory compliance and accurate data management collection for multiple cancer trials. The Regulatory Coordinator will work with investigators, study staff, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies to ensure that regulatory requirements for clinical trials are met. This position does not involve patient contact, but may include data abstraction from patient records.

Responsibilities

• Schedule and facilitate pre-activation activities including pre-site qualification visits, SIVs, and facility tours
• Complete feasibility questionnaires for upcoming studies
• Assist in start-up and implementation activities for new studies
• Completion and submission of clinical trials amendments to the IRB
• Correspondence with the IRB, investigators and sponsors throughout the clinical trial process
• Prepares annual progress reports for IRB renewal of ongoing studies
• Collection, completion, and submission of regulatory documents to various regulatory entities
• Maintenance of regulatory binders and other relevant files during the review, approval, and activation process for Clinical Trials
• Coordinates Review & Processing of Safety Reports to the IRB
• Manages data collection via chart abstraction and submits data in timely fashion
• Manages and possibly reports Adverse Events & Deviations reported to the IRB and Sponsors
• Resolves data discrepancies as requested by Sponsors
• Participates in monitoring visits as requested by Sponsors and makes data corrections as required by Monitor

Qualifications

• EDUCATION: BA/BS required
• CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED: Human Subject Protections Certification, GCP Certification
• EXPERIENCE: Minimum of one year of experience in a research setting

Seniority level

• Associate

Employment type

• Contract

Job function

• Other

Industries

• Pharmaceutical Manufacturing
• Biotechnology Research
• Research Services