Clinical Research Coordinator II

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Full Time Front Office Pasadena, CA, US

4 days ago Requisition

Salary Range: $30.00 To $38.00 Hourly

Job Title:

Clinical Research Coordinator II

Reports to:

Research Regulatory/QC Manager

Location:

Sherman Oaks and Travel within Greater Los Angeles, CA

The Clinical Research Coordinator II is a critical, high-autonomy role that makes clinical research accessible to our patient population while providing administrative support to the clinic. Working on behalf of the Principal Investigator (PI), this individual independently manages the full study lifecycle—from feasibility and start-up, through patient recruitment, eligibility assessment, and follow-up, to the preparation and gathering of all data and documents for this highly regulated process.

This role is best suited to a coordinator who has run trials with significant independence at a smaller or independent site, is comfortable owning multiple functions at once, and can train and mentor less experienced coordinators as our research program grows.

• 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
• Trains, mentors, and provides day-to-day guidance to less experienced coordinators and clinic staff on research processes, GCP, and site systems; serves as a point of escalation for research-related questions
• Independently owns day-to-day research operations for the site with minimal oversight, exercising sound judgment to prioritize competing study demands

• Works in clinic to operate clinic cleanly, safely and efficiently
• Prepares exam and treatment rooms per cleaning protocols; assists with all processes (within scope of certification) to maintain inventory of supplies, medication, and equipment necessary for the operation of the clinic.
• Keys data into EMR/forms to maintain accurate office and patient records
• Organizes tasks to facilitate smooth work/patient flow
• Schedules and registers patients; referrals to specialists as appropriate
• Handles routine administrative tasks (filing, correspondence, mail) as needed to support clinic operations
• Adheres to all company policies and procedures, business conduct and work compliance standards
• Will be required to travel and work at multiple clinics within a reasonable driving distance from home clinic
• Any other task reasonably requested by company to meet its goals

• Effective use of computerized patient care system
• Knowledge of medical terminology
• Knowledge of all safety requirements when handling biohazardous specimens or contaminated instruments
• Strong interpersonal skills to interact with patients, families, ancillary departments, physicians and…