Supports Physicians Dialysis Research by working under the supervision of the Principal Investigator (PI), Director and other site personnel as applicable. Conceptually applies the research protocol to the clinical setting to allow for accurate and timely completion of all duties. Maintains appropriate documentation associated with the assigned clinical study. Ensures studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), ICH, and FDA guidelines.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines Under the supervision of the Principal Investigator (PI), prepares and submits regulatory documents in an accurate and timely manner In collaboration with the PI, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria Obtains informed consent according to GCP Schedules subject visits Prepares labs/tests per protocol Completes case report forms in timely manner Responsible for study drug storage and drug accountability according to the parameters of the study protocol and sponsor requirements Administers the investigational product according to the parameters of the study protocol and under the direction of the physician. LVNs/LPNs may administer medications under their state licensure and under the order of the PI. Non-LVNs may administer oral and subcutaneous drugs with appropriate training and under the license of the PI. Monitors and evaluates patients’ condition with regard to the investigational product Consults with PI regarding the appropriate administration of investigational product Conducts routine assessments to evaluate the subject’s response to investigational product, and communicates observations to the PI, sponsor and IRB as appropriate Educates the subject about the applicable study particulars Informs/updates the subject about pertinent study details as needed Documents subject information as it pertains to the clinical study according to the principals of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) Meets with the study monitor to review, verify and correct all data entered onto the case report form and to ensure appropriate maintenance of study records Reports at a minimum weekly to the PI on progress on the study Reviews all lab/tests with the physician in a timely manner Reports subject’s progress, complaints and issues to PI, study sponsor, or IRB as needed in a timely manner Conducts ongoing assessments of the overall study execution within the facility/practice, communicating concerns to the Director, PI, study sponsor or IRB as needed Notifies PI, study sponsor and IRB of Serious Adverse Events according to protocol Collects pre-study essential documents to protocol RB as needed according to GCP and files appropriately in the study record Maintains the study file record according to GCP Maintains subject participant records according to GCP Provides a list of all study participants to facility/practice management to avoid improper billing of lab tests or services covered under the research budget Ensures appropriate storage, access, and maintenance of records pertaining to investigational product Documents investigational product received dispensed, and returned to study sponsor according to GCP Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner Attends Investigator Meetings as necessary Other duties as assigned
Experienced candidates only
RESPONSIBILITIES INCLUDE: Recruitment/Consent Maintaining and dispensing study product and supplies Manage clinical staff Lead site visits Maintaining source documents Report adverse events
REQUIREMENTS: At least 5 years’ experience as a coordinator GCP and IATA certification Must be proficient with Microsoft Office Applications Spanish preferred Nephrology/Dialysis experience preferred Real Time CTMS preferred
About Physician Dialysis
Physicians Dialysis provides high-quality dialysis care. We have widespread recognition and a two-decade history of industry-wide respect and recognition. The members of our executive team lead by example and play an active role in dialysis operations. If you are looking for a rewarding career in the health care industry, Physicians Dialysis has a position for you. We are seeking a highly qualified Registered Nurse to work full-time in a correctional facility