What are the responsibilities and job description for the Clinical Research Coordinator position at Wallace Rheumatic Studies Center Ll?
Benefits : 401(k) Competitive salary Dental insurance Health insurance Paid time off Vision insurance
Major Duties & Responsibilities
Research
- Works with PI to meet or exceed study enrollment as per Sponsor’s inclusion / exclusion criteria
- Complete feasibility questionnaires based on site information and all regulatory start up packages
- Recruits and enrolls patents in a friendly and professional manner, screening for eligibility criteria
- Conducts patient visit, collects all required data in appropriate formats, and follows up with all subjects as appropriate
- Reports, tracks and follows up on an all adverse events, protocol waivers, deviations and violations
- Complies with all study protocol, SOP and reporting requirements in a timely manner
- Responsible for completion of all required documentation with keen focus on the integrity of the data submitted by careful source document review, monitoring for missing data and / or inconsistencies.
- Maintains thorough and accurate records per regulatory / compliance standards at all times including but not limited to data for potential inspection; signed informed consents, source documentation, drug dispensing logs, subject logs, and all study related communication
- Creates study specific tools for source documentation when not provided by sponsor
- Collects, completes and enters data into study specific forms and / or electronic data capture system
- Appropriately handles and records all specimens; prepares specimens for shipment; tracks all shipments; tracks all inventory and calibrations.
- Attends relevant meetings (e.g. SIVs, PSSVs, IMVs, COVs, audits); assists Sponsor and FDA with any audits and responds to any monitoring / audit findings
- Actively communicate with stakeholders as appropriate (Sponsor, IRB, vendors) and maintain active communication on status of each study with PI and management as directed
Salary : $65,000 - $70,000