Clinical Research Coordinator

Company: Veridoc R&C
Location: Harlingen
Posted on: November 24, 2022

Job Description:

*Research Coordinator Responsibilities *
All general research responsibilities, in addition to the below:
* Maintain regulatory site binders
* Maintain subject binders
* Identify subjects eligible for studies using inclusion and exclusion criteria from the study protocols
* Correspond with Sponsors/CROs/CRA on a daily basis
* Review ICF with subjects and their friends/family, providing detailed informed consent while giving the patient as much time as necessary to make a decision. When unable to answer questions or concerns, an investigator should always be consulted
* Ensure all research personnel are appropriately delegated, trained, and that training is documented prior to any performing study-related assessments/activities
* Maintain certification (GCP, IATA, misc. study certification)
* Verify that all necessary personnel remain certified on your studies
* Review IBs, Study Procedures and Manuals (including but not limited to BCVA manual, Lab manual, photography manual), as well as study Protocol
* Ensure all study assessments are carried out per protocol on a daily basis
* Upload images to the reading center for subject visits in a timely manner (the same day images are obtained)
* Enter data into EDC in a timely manner (it varies based on Sponsor/CRO requirements, but should be no later than 2 days after subject's visit)
* Answer queries in a timely manner (varies based on Sponsor/CRO requirements, but should be no later than 5 days after subject's visit)
* Identify and report AEs and SAEs appropriately
* Update the PI/sub-I's of relevant study information, as applicable
* Maintain training logs and DOA logs in the ISFs
* Check the IRB portal weekly (and before every screening visit) to ensure the most up to date ICF and other patient information is being utilized
* Complete source documents on a daily basis. Information for visits should be obtained in real time and not transposed from EMR or other locations
* Train all site staff on the protocol (in conjuncture with the PI)
* Ability to obtain routine vitals
* Phlebotomy/lab processing and shipping
* IP accountability log and supply
* Review/audit source documents for accuracy and completeness (ability to do so many vary by study)
* Create and maintain source documents for upcoming and ongoing studies
* Verify with the IRB available patient materials prior to dispensing items to patients, and other recruitment/referral items through the IRB portal prior to sending documents (i.e. letters to
PCPS regarding subjects in studies, etc)

Requirements and Qualifications
* Clinical Research experience
* Stroke experience preferred
* Ability to multitask, prioritize, and manage time efficiently
* Ability to adequately communicate with Sponsors/CROs and other physicians
* Self-directed and able to work without supervision
* Proficient computer skills, including but not limited to, Microsoft Office Suite, NextGen EMR system (or experience with any other EHR system)
* Ability to stand and sit for long periods of time
* Ability to take call one a month for a week at a time
* Team oriented mind-set
* Flexible and open-minded to change
* Desire to continuously learn new things

Job Types: Full-time, Contract, Part-time

Pay: $20.00 - $28.00 per hour

Benefits:
* Health insurance
* Paid time off
Schedule:
* 8 hour shift
* Monday to Friday
* On call

Ability to commute/relocate:
* Harlingen, TX 78550: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Experience:
* Clinical Research: 1 year (Preferred)

Work Location: One location%58047475%

Keywords: Veridoc R&C, Harlingen , Clinical Research Coordinator, Healthcare , Harlingen, Texas