28 days old

Clinical Research Coordinator

Methodist Health System
Omaha, NE 68102
  • Job Code

  • Purpose of Job
    • Coordinates clinical research studies of investigational medications, including but not limited to: regulatory compliance, study start-up phase, implementation of study, follow-up of research subjects, closeout of study, and study record maintenance. Conducts registry studies for data collection and observation (short and long term). Ensures proper billing services. Evaluates and ensures proper follow-up care is provided for all research subjects.
  • Job Requirements
    • Education
      • Associates degree in healthcare discipline or relevant field required.
      • Bachelor's degree preferred. Will consider relevant work or educational experience.

    • Experience
      • A minimum of 1 year of experience with clinical trials and/or regulatory experience required.

    • License/Certifications
      • Certified Clinical Research Coordinator (CCRC) preferred but required within 2.5 years of employment.
      • International Air Transport Association (IATA) - Dangerous Goods Regulation (DGR) training preferred.
      • Collaborative Institutional Training Initiative (CITI) program certification required within 30 days of hire.
      • Basic Life Support (BLS) from an accredited American Heart Association or Red Cross vendor/instructor required.

    • Skills/Knowledge/Abilities
      • Knowledge of research study design for clinical trials, Phase I - IV.
      • Knowledge of medical terminology, cardiac anatomy, physiology, and conduction system.
      • Knowledge of Good Clinical Practice (GCP) regulations/guidelines and federal regulations surrounding the conduction of human research.
      • Knowledge of HIPAA guidelines, legal and ethical considerations related to patient and company information.
      • Skill in effective written and verbal communication.
      • Skill in operating office equipment including a personal computer, EMR, practice management system, scanner/fax/copy machine, pager and telephone systems.
      • Skill in obtaining vital signs and performing phlebotomy services.
      • Skill in query resolution.
      • Ability to conduct trials under the direction of a Principal Investigator.
      • Ability to recruit and consent patients according to appropriate guidelines.
      • Ability to establish and maintain effective working relationships with those contacted outside of HC in the course of daily work.
      • Ability to organize time and materials effectively achieving department goals.
      • Ability to accurately type 40 WPM.
      • Ability to work collaboratively with physicians, managers, and other staff in a professional manner to promote effective team building.

  • Physical Requirements
    • Weight Demands
      • Medium work - Exerting up to 50 pounds of force

    • Physical Activity
      • Not necessary for the position (0%):
        • Climbing
        • Crawling
        • Kneeling
        • Sitting
      • Occasionally Performed (1%-33%):
        • Balancing
        • Carrying
        • Crouching
        • Distinguish colors
        • Keyboarding/typing
        • Lifting
        • Pulling/Pushing
        • Repetitive Motions
        • Stooping/bending
        • Twisting
      • Frequently Performed (34%-66%):
        • Balancing
        • Carrying
        • Crouching
        • Distinguish colors
        • Keyboarding/typing
        • Lifting
        • Pulling/Pushing
        • Repetitive Motions
        • Stooping/bending
        • Twisting
      • Constantly Performed (67%-100%):
        • Fingering/Touching
        • Grasping
        • Hearing
        • Reaching
        • Seeing/Visual
        • Speaking/talking
        • Standing
        • Walking
    • Job Hazards

      • Not Related:
        • Electrical Shock/Static
        • Radiation Non-Ionizing (Ultraviolet, visible light, infrared and microwaves that causes injuries to tissue or thermal or photochemical means)
      • Rare (1-33%): - Radiation Alpha, Beta and Gamma (particles such as X-ray, Cat Scan, Gamma Knife, etc)
      • Occasionally (34%-66%):
        • Physical hazards (noise, temperature, lighting, wet floors, outdoors, sharps) (more than ordinary office environment)
        • Equipment/Machinery/Tools
        • Explosives (pressurized gas)
      • Frequent (67%-100%):
        • Chemical agents (Toxic, Corrosive, Flammable, Latex)
        • Biological agents (primary air born and blood born viruses) (Jobs with Patient contact) (BBF)

  • Essential Job Functions
    • Essential Functions I

      • Trial Management- Clinical or Device

        • Verifies investigator/site feasibility, facilitates site budget/contract approval process, and develop timelines for conducting and completing the trial, as well as manage financial agreements.
        • Attends Investigator Meetings as required.
        • Prepare and submit initial study submission to IRB/IEC and/or sponsor for review and approval.
        • Select the investigational staff and assign roles and responsibilities, ensuring appropriate training of staff.
        • Maintain trial master file (e.g., regulatory binder), Identify minimum regulatory document requirements for site trial master file (e.g., country-specific regulatory documents), while ensuring IRB/IEC review/approval of study and study documents.
        • Develop and follow a recruitment strategy and study management plan, maintain screening/enrollment log and ensure trial subject retention.
        • Select and manage local vendors (e.g., laboratory, x-ray, MRI), and maintain current vendor credentials (e.g., lab certification/licensure and normal ranges) as applicable.
        • Prepare study documentation (e.g., schedule of events, description of procedures) as well as modifying per protocol amendments require.
        • Search clinical databases for potential participants, and schedule participants for protocol specific procedures, including multi-department visits as indicated in protocol.
        • Conduct informed consent, working with the participant's the trial Investigator and/or Primary Care Physicians to ensure the participant understands study design.
        • Collect, record, and report accurate and verifiable data, conducts participant visits according to requirements, documenting protocol deviations/violations and implementing corrective actions plans as applicable.
        • Enter and transmit data, as well as review and resolve CRF queries from the study monitor/data management.
        • Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO ensuring timely review of study data (e.g., laboratory results, x-rays).
        • Manage study supplies (e.g., lab kits, case report forms), equipment (e.g., calibration and preventive maintenance), and study record retention and availability.
        • Coordinate study monitoring visits, including site initiation, interim and close-outs.
        • Prepare study documents and study summary and/or close-out letter for IRB/IEC.
        • Interrogate implantable cardiac devices (i.e. pacemakers, defibrillators).
        • Analyze implantable cardiac devices, perform diagnostic tests, and make appropriate device programing changes.
      • Trial Oversight

        • Ensure adequate site management, while being compliant with electronic data requirements (e.g., electronic health records, eCRF).
        • Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect confidentiality by limiting unauthorized access.
        • Respond to or facilitate response to audit/inspection findings.
        • Ensure proper adverse event reporting by the investigator.
        • Escalate problems to appropriate in-house management.
        • Investigate and/or report potential fraud and misconduct.
        • Ensure follow-up medical care for study subjects is documented, as applicable.
        • Ensure staff, facility, and equipment availability throughout the study.
        • Ensure compliance with study requirements and regulations.
      • Safety

        • Assess participant safety during trial participation, by reviewing participant's medical records, as well as self-reported adverse events.
        • Collaborates with physicians and nurses to coordinate a patient's plan of care to prevent duplication of patient services and to ensure continuity of care.
        • Minimize potential risks to subject safety, oversee safety risks (e.g., clinical holds, product recalls), handle medical monitor oversight.
        • Report required adverse events to Sponsor/CRO, regulatory authorities, and/or IRB/IEC, ensure proper documentation of adverse events, coding correctly (e.g., serious, severe, moderate, mild, expected, unexpected, and causality).
        • Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts).
        • Manage and motivate the investigational staff and other disciplines involved, and take measures to minimize any potential risks.
        • Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit progress reports to the IRB/IEC per requirements.
        • Review common laboratory values and alerts, review for potential subject safety issues (e.g., toxicity, significant lab values).
        • Implement Investigator's plan of action for management of adverse event (e.g., stop investigational product; call, retest, treat subject).
        • Maintain follow-up to determine resolution of adverse event.
        • Document follow-up medical care for study subjects, as applicable.
        • Conduct safety monitoring/reporting activities.
        • Initiate un-blinding procedures.
      • Protocol

        • Evaluate and review protocol for feasibility, review protocol during Investigator's meeting.
        • Possess knowledge of protocol development, submission, and approval process, including protocol amendment submission and approval procedures.
        • Understand clinical trial phases, study design characteristics, (e.g., double-blind, crossover, randomized), and study objective.
        • Verify the eligibility of potential trial subjects, reviewing inclusion/exclusion as defined by the protocol.
        • Execute study per protocol, following description of procedures (e.g., vitals, blood collection, EKG).
        • Ensure proper collection, processing, and shipment of biological specimens (e.g., centrifuge, preparation of slides, freezing, and refrigeration).
      • Investigational Product Management

        • Ensure adequacy of investigational product and other supplies at site.
        • Ensure randomization and emergency codes of investigational product have been maintained.
        • Ensure proper storage, dispensing, handling, and disposition of investigational product and other supplies.
        • Reconcile, maintain, prepare, dispense, and retrieve investigational product.
    • Essential Functions II

      • Participates in mandatory in-services and/or CE programs as mandated by policies and procedures/external agencies and as directed by management.
      • Follows and understands the mission, vision, core values, Employee Standards of Behavior and company policies/procedures.
      • Other duties as assigned.

Posted: 2020-09-03 Expires: 2020-10-02
Sponsored by:
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Sponsored by:
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Clinical Research Coordinator

Methodist Health System
Omaha, NE 68102

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