About this opportunity
Integrated Resources, Inc ( IRI ) lists this Clinical Research Coordinator opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
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
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.