Clinical Research Coordinator

Saint Ann, Missouri

Posted: 12/01/20 Category: Professional Job Number: 9828

Job Description

Position: Clinical Research Coordinator
Location: Saint Ann Missouri 
Job Type: Contract
Duration: 6 months 



  • Works 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 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.

  • 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) and appropriate management 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.
  • 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.
  • 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 appropriate management and external parties 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 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.

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Day to day work includes desk and personal computer work and interaction with patients, facility staff and physicians.
  • The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials.
  • The position requires 10 – 15% travel between assigned facilities and various locations within the community.
  • Travel to regional, Business Unit and Corporate meetings may be required.

  • None

  • Graduate of a technical program in healthcare (e.g. LVN/LPN, Medical Assistant or Dialysis Technician) AA in Life Sciences or other health related field. Advanced Degree preferred.

  • Research experience strongly preferred.
  • 2 to 5 years’ healthcare experience with nephrology patients 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.

Meet Your Recruiter

Meg McLeish
Technical Recruiter

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