Careers at PCRI

Position Summary

Expert on assigned trials as the Lead Study Coordinator where they are responsible for ongoing, active communication of study progress and questions. Oversees all aspects of the trial. Delegates tasks appropriately and ensures all appropriate staff have necessary training. Preforms study visits.

Essential Job Functions

• Lead Study Coordinator on 4-8 trials at a time
  • Be an expert on assigned trials, overseeing all aspects of the trial with oversight by the PI
  • Responsible for ongoing, active communication of study progress, questions, issues with Investigator and sub-investigator
  • Lead Study Review on assigned trials
  • Ensure appropriate staff have all necessary documented training on assigned trials
  • Ensure PCRI delegation of Authority log has been signed doff appropriately prior to individuals prior to performing study-related tasks
  • Ensure study source documents for assigned trials reflect all necessary data points per protocol and data capture system, using the PCRI template and process (clerical assistance) including inclusion/exclusion and appropriate involvement of PI and in conjunction with QA director template and review
  • Ensure all study supplies for assigned trials are received and sufficient for study goals
  • Ensure study drug is dispensed, accounted for, and returned to the Sponsor per protocol
  • Act as the Sponsor’s monitor primary site contact
  • Ensure SAE’s are reported to Principal Investigator, Sponsor, and IRB (through Regulatory) in a timely manner, collect all information to report the event, follow up appropriately
  • Ensure complete and timely review of all study procedures
  • Responsible for delegating work, outcomes, and general oversight of their assigned Research Assistant

• Perform study visits
• Accurately complete study sources for any of the site’s ongoing studies once delegated and trained on the protocol prior to performing study-related tasks

2 years of clinical nursing experience required. Strong clinical background with evidence of independent clinical assessment skills and strong attention to detail preferred.

RN/ LPN from 2, 3, or 4-year program is required.

CCRC preferred not mandatory at the time of hire.

 

Position Summary

Performs all delegated support tasks for the Study Coordinators. Ensure quality and timely data entry as well as preparation of charts. Conduct Quality Assurance / Quality Control review of patient data to ensure accuracy.

Essential Job Functions

• Perform delegated support tasks for Study Coordinators
  • Chart preparation
  • Accurate and timely data entry (EDC)
  • Prepare for monitor visits
  • Perform vitals, EKG’s and other study procedures as directed by Study Coordinator
  • Conduct Quality Assurance / Quality Control review of patient data
• Keep all study lab kits organized and in stock
• Organize and track study storage for archived studies

Previous medical office, research, or hospital experience desirable.

Training and evidence of competencies are reviewed by a supervisor to determine RA level.

High School Diploma required.

An associate’s degree in medical assisting or experience as a nursing assistant is preferred.

Position Summary

Performs study visits under the direction of PI and study coordinator. Provides support to PCRI team as needed and delegated.

Essential Job Functions

• Facilitate visits per protocol at the direction of the PI
  • Follow the research protocol directly
  • Adhere to good clinical practices
  • Responsible for ongoing, active communication of study progress, questions, issues with Investigator and sub-investigator
• Ensure study source documents for assigned trials reflect all necessary data points per protocol and data capture system, using the PCRI template and process (clerical assistance) including inclusion/exclusion and appropriate involvement of PI and in conjunction with QA director template and review.
• Perform study visits and accurately complete study sources for any of the site’s ongoing studies once delegated and trained on the protocol.
  • Administer informed consent to subjects according to PCRI’s processes
  • Review and document subject’s inclusion-exclusion criteria, ensure all criteria are met prior to Principal Investigator signing off on randomization
  • Review and document subject’s medications and indications for use
  • Perform vitals, ECG’s, phlebotomy, and other tests as delegated and needed (site support staff available)
  • Collect and report Adverse Events
  • Follow protocol
  • Adhere to good clinical practice
• Complete study sources for any of the site’s ongoing studies once delegated and trained on protocol

Strong clinical background with evidence of independent clinical assessment skills and strong attention to detail preferred.

A minimum of a 4-year degree in the science field is required.

Position Summary

Carries out all necessary lab work, draws, processing, storage, and shipment as needed for clinical trials.

Essential Job Functions

• Be the expert for all laboratory portions of clinical trials
  • Review each study’s laboratory manual, lab logs, etc for various ongoing/upcoming studies
  • Meet with Lead Study Coordinator prior to study start to review necessary logs, tips, and tricks, and ensure proper lab set up
  • Present lab tips and tricks during “Study Review Meeting”
  • Greet subjects in the lab, perform all phlebotomy, processing (centrifuge and aliquot blood samples and perform other tests as needed), storage, and shipping of specimens per study-specific laboratory manual and compliance with other regulations eg. (IATA)
• Lab inventory and planning
  • Upon receipt of initial study lab kits the Lab Technician is responsible for:
    • Notifying Lead Study Coordinator and Research Assistant of receipt
    • Finding appropriate storage location and organization system for all kits
    • Reviewing the lab kit and requisition for set up
• Documentation
• Lab Maintenance

Phlebotomy experience is required.

A High School diploma is required.

MLT preferred phlebotomy a must.