What are the responsibilities and job description for the Clinical Operations Specialist position at Integrated Resources, Inc ( IRI )?
Title :Clinical Study Associate II
Location -Cambridge MA -Remote
Duration -8 months
Duties:
What You’ll Do
Support the Clinical Operations Study Leader and team in managing and overseeing clinical trials. Reports to an Associate Director of Clinical Operations (or above).
Responsibilities
Assist in day-to-day trial execution: site start-up, enrollment, monitoring, and data flow.
Prepare study documents (consent forms, site instructions, manuals, pharmacy binders).
Track essential documents in TMF; review site documents for accuracy.
Monitor patient status and sample collection; manage lab schedules and vendor coordination.
Liaise with CROs and sites for sample handling and reporting.
Review monitoring reports, data queries, and site performance metrics.
Attend site visits and co-monitor with CRO.
Ensure data quality and resolve eligibility/protocol deviation issues.
Support investigator/vendor meetings and feasibility assessments.
Review site contracts and budgets; coordinate third-party vendor activities.
Education:
Qualifications
Bachelor’s degree in science or higher.
Skills:
Qualifications
Capabilities
Resourceful and flexible in dynamic environments.
Highly organized with strong multi-tasking skills.
Collaborative team player.
Self-Starter & Results Driven: Takes initiative, identifies opportunities, and drives deliverables with minimal supervision.
3 years in pharma, CRO, or clinical research environment.
Knowledge of GCP and SOPs; understanding of study phases.
Proficient in Word, Excel, PowerPoint; database management basics.
Strong verbal and written communication skills.
Preferred
Medical/scientific experience in clinical research.
Experience in monitoring, study coordination, or data handling
Salary : $60 - $63