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Clinical Study Associate II

SOPS
Contracts
Metrics
Team Player
Self-Starter
Very Organized
Clinical Operations
Clinical Study
Clinical Research
Clinical Trials
GCP
CRO
Description:

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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.

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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

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Qualifications

  • Bachelor’s degree in science or higher.
QUALIFICATION/ LICENSURE :
  • Work Authorization : Green Card, US Citizen
  • Preferred years of experience : 3+ Years
  • Travel Required : No travel required
  • Shift timings: Not specified
Job Location Cambridge, Massachusetts
Pay USD 60.00 - USD 65.00 Per Hour
Contract Duration 6 month(s)