· Possess superior knowledge of drawing blood via venous access. Able to collect, process, store, package and ship samples based on study or clinic requirements Phase I- IV.
· Current IATA Certification
· Perform EKG’s based on each study or clinic requirement. Complete any maintenance required EG: Replenish/ ordering of paper/ run testing strip/clean (after each use) and/or replace leads/receive and/or return of equipment to sponsor, ensuring any paper invoicing is given to the regulatory department for filing.
· Perform Vital Signs set forth by protocol requirement and/or Clinic. This shall include Manual and/or Automatic collection. Knowledge of acceptable result ranges set forth by Physician/PI. Any outside range of result shall be reported immediately upon discovery to the Physician/ PI.
· Assist clinic MA when requested – required knowledge of all instruments/ equipment used in daily procedures. How to set up patient rooms to ensure all medical staff have appropriate tools required to perform tasks. Knowledge of how to care for each instrument – this includes the sanitizing of each item based on clinic training (provided)
· NextGen – Entering data/updating data/printing records and uploading documents. (Not all inclusive) Confirming appointments and rescheduling appointments if necessary. All Clinic directives and oversight will be provided by Office Manager and/ or Physician
· Knowledge of CTMS (Training will be provided upon hire – basic fundamentals should be in place within 90-day probationary period)
· Accurate scheduling/rescheduling/cancelling of appointments, must be cross verified with NextGen to provide the entire clinic with knowledge of who is expected and why they are here. This will ensure patient flow.
· Maintain a copy of Physician/PI surgery schedule which will be provided by clinic staff. Schedule will be added to CTMS and updated PRN so research staff has the knowledge of availability prior to scheduling appointments.
· Perform and/or assist with any protocol procedure including but not limited to: PAP, SIS, US, DXA, EB. Training on procedures will be provided by Physician/PI and/ or Sponsor/CRO.
· Maintenance of equipment including study required calibrations, transmission of test (if required), immediate reporting of faulty equipment, cleaning of equipment set forth by OM/Physician, and timely completion of any sponsor required training (initial or update).
· Maintain week-day temperature logs in Pharmacy.
· Possess superior knowledge of required temperature guidelines to ensure Investigational Product is properly stored and temperature controlled set forth by each protocol. Any and all excursions should be reported to Site Director/ Regulatory Manager and PI upon discovery.
· Maintain weekly inventory of all lab kits and lab related product. Ordering of additional kits/product should be completed based on protocol requirements and all receipts provided to the Regulatory Department for filing.
· Assist CRC with recruitment efforts. RA must attend any and all Sponsor/CRO Site Initiation Visits and participate with any questions or concerns based on their job description and after protocol review. This is to ensure each study protocol is executed and understood accurately.
Qualifications and Education Requirements
High School Diploma
Phlebotomy Certification and/or minimum of 1 year experience in clinic or research setting
ECG Placement and Collection
Vital Sign collection- both manual and electronic