Clinical Research Coordinator

Company: Fresenius Medical Care North America
Location: Baton Rouge
Posted on: March 26, 2020

Job Description:

PURPOSE AND SCOPE:Works under the supervision of the Principal Investigator (PI), Director and other site personnel as applicable. Conceptually appliesthe research protocol to the clinical setting to allow accurate and timely completion of all duties. Maintains appropriate documentationassociated with the assigned clinical study. Ensures studies are conducted according to established company policies and proceduresas well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), ICH, and FDA guidelines.SUPERVISION:? None?EDUCATION:? Graduate of a technical program in healthcare (e.g. LVN/LPN, Medical Assistant or Dialysis Technician) AA in Life Sciencesor other health related field. Advanced Degree preferred.EXPERIENCE AND REQUIRED SKILLS:? 2 to 5 years' healthcare experience with Dialysis experience preferred.? Research experience preferred.? Willing to pursue CCRC or SoCRA certification when eligible.? Current appropriate state licensure if applicable.? Proficient with PCs and Microsoft Office applications.? Good communication and organizational skills.? Ability to work independently.PRINCIPAL DUTIES AND RESPONSIBILITIES:? Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordancewith FDA, GCP, and ICH Guidelines.? Under the supervision of the Principal Investigator (PI), prepares and submits regulatory documents in an accurate and timelymanner.? In collaboration with the PI, incorporates clinical judgment and knowledge of protocol to identify potential study participantsaccording to inclusion and exclusion criteria.? Obtains informed consent according to GCP.? Schedules subject visits.? Prepares labs/tests per protocol.? Responsible for study drug storage and drug accountability according to the parameters of the study protocol and sponsorrequirements.? Administers the investigational product according to the parameters of the study protocol and under the direction of thephysician. LVNs/LPNs may administer medications under their state licensure and under the order of the PI. Non-LVNs mayadminister 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 observationsto 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 appropriatemaintenance of study records.? 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 theDirector, 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 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 coveredunder 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.

Keywords: Fresenius Medical Care North America, Baton Rouge , Clinical Research Coordinator, Healthcare , Baton Rouge, Louisiana