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DATE ADDED: Mon 01/10/2018

Clinical Research Coordinator

Charleston, USA
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COMPANY: SMG HUMAN RESOURCES

Job Description

*Our Ideal Candidate will have a combination of patient care - with direct contact working with patients as well as exposure to Pharmaceutical Research.

Job Description:* Responsible for the implementation and coordination of clinical research studies and clinical trials. Two years experience in research program coordination required.

Key Duties:

  • · Recruit, obtain informed consent, screen and enroll patient research subjects in suitable studies/clinical trials
  • · Review of Medical History of patients against Inclusion/Exclusion Criteria of studies
  • · Schedule patient visits according to study protocol visit window and coordinator/investigator schedule
  • · Performs Patient Visit Reminders, Visit Confirmations and/or Rescheduling of Visitsi.e. due to investigator schedule change, subject requests a change and any other reason
  • · Meet with patient research subjects and perform visit requirements
  • · Gather all medical info available since the last visit
  • · Review for adverse events and any changes in patient history
  • · Assessments of vital signs, phlebotomy, specimen collection and lab processing and shipment
  • Immediate collection of all data pertaining to patient visits and immediate completion of paperwork to be sent to Sponsor Medical Director (via EDC or as directed by sponsor of study)
  • · Confirm all required data is collected and transferred to case report
  • · Complete all Case Report Forms (CRFs) before all monitoring visits during the study
  • · Be on hand throughout the visit to answer questions and facilitate the monitoring visit
  • · Resolve all issues possible while the Monitor is on site
  • · Collection of required documentation and physician investigator signatures for Protocol
  • · Communicate with physicians, ancillary personnel, hospital departments
  • · Communicate with Sponsor/CRO; obtain required documents
  • · Coordinate with physicians, hospital, coordinators schedules and other departments for scheduling the trials and visits
  • · Reserving the conference room and coordinate with sponsor representative for all site visits and Investigator Meetings
  • · Coordinate all Investigator Meetings (whether webinars or when travel is required) ·Receiving supplies, review inventory (devices, drugs)
  • · On occasion, review new Study Protocol for feasibility, capability, logistics,personnel needs
  • · Getting information and advertisements out in community and in to physician investigator’s practices
  • ·Update CTMS study visit tracker upon entry into Study EDC system
  • · Follow-up reports of SAE whenever new information/data is obtained
  • · Request patient medical records from ER, hospitals, other physicians
  • · Update and ensure that all device and/or drug accountability is current
  • · Work on other projects as directed by the Site Director

Experience:

  • · Knowledge of basic hospital activities.
  • · Ability to conduct clinical research with a strong attention to detail is required.
  • · Ability to lead by example, work independently and conduct daily operations in accordance with instructions from the Site Director.
  • · Excellent oral and written communication skills are essential.
  • · Strong critical thinking and problem solving are required.
  • · Strong computer skills.
  • · Knowledge of clinical research study principles including appreciation for protocol adherence and human subject research ethics.
  • · Experience with program management in a pharmaceutical, medical device or academic research environment preferred.
  • · Prior work with clinical research or patient care preferred.


Role: Clinical Research Coordinator
Job Type:
Location: Charleston,

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