Nebraska Methodist College

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Clinical Research Coordinator Diabetes and Endo Clinic - Diabetes & Endocrine

at Nebraska Methodist College

Posted: 5/24/2019
Job Reference #: 231170

Job Description

Req Number:
13554

Company:
Methodist Physicians Clinic

Located at:
Omaha, NE

Work at :
Omaha

Department:
Diabetes & Endocrine

Status:
Full Time

Shift:
Day Shift

Hours:
40

Hours Per Week:
40

Starting Hourly Rate:
20.35

Contact Information:
  • Contact: Adrienne Pitzl


Job Details:
  • Associate's Degree
  • 1 to 2 years experience required
    • 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.