*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.
- · 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
- · 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
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