Clinical Study Associate II
Job Description
Job Summary:
- Support the Clinical Operations Study Leader and team in managing and overseeing clinical trials.
- Reports to an Associate Director of Clinical Operations (or above).
Duties and 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 and Experience:
- Bachelor’s degree in science or higher.
- 3+ years in pharma, CRO, or clinical research environment.
- Medical/scientific experience in clinical research.
- Experience in monitoring, study coordination, or data handling.
Knowledge, Skills and Abilities:
- 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.
- Knowledge of GCP and SOPs; understanding of study phases.
- Proficient in Word, Excel, PowerPoint; database management basics.
- Strong verbal and written communication skills.
Schedule Hours Per Week: 40.00
Schedule Hours Per Day: 8.00
Schedule Days Per Week: 5.00