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Clinical Research Coordinator

Company: Memorial Health
Location: Decatur
Posted on: November 15, 2020

Job Description:

Manages Research Study Activities.

Education and/or Other Requirements
A bachelors degree in nursing or other health-related field is preferred. Pertinent LPN or RN licensure/registration must be maintained. Previous research experience and/or recent nursing experience is preferred.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Must possess good communication and interpersonal relationship skills. Must be able to organize work with minimal supervision. Must be able to focus attention to minute details. Access, Work and Excel computer skills required. Environmental Factors
    Direct patient care duties involve the potential for frequent exposure to blood and body fluids.
    Physical Demands
    The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job.
    • Must be able to walk, stand, stoop, kneel and assist in lifting patients; able to assist patients and/or adjust equipment at floor level; able to reach, change and read IV's 5 feet from the floor unaided; able to support persons (possibly 200 pounds or more) in emergency situations; able to move quickly from place to place on occasion, including from floor to floor in emergency situations; able to utilize fine motor control in hands for tasks such as medication preparation and administration; able to hear to take blood pressure and to hear breath, heart and bowel sounds. Must possess visual acuity to meet visual demands in charting and operating equipment.
      Mental Demands
      • While performing the duties of this job, the employee must be able to work under stress, adapt to changing conditions and meet strict time guidelines.
        • Ability to adhere to strict confidentiality requirements.
          Reasonable accommodations may be made to assist an otherwise qualified individual in the performance of the job. In order to meet the needs of the Company employees may be assigned other duties, in addition to or in lieu of those described above.

          Essential Functions and Job Duties
          • Coordinates screening and enrollment of clinical trial patients.
            • Ensures eligibility requirements are met and reviews with investigator.
            • Assists investigator in explaining and educating patient and family on protocol and informed consent.
            • Obtains informed consent from potential study candidates and / or families.
            • Continues informed consent process with study patients through duration of participation
            • Obtains re-consent in a timely manner
            • Manages patient enrollment via guidelines established by study protocol.
            • Ensures protocol required testing is ordered and completed as outlined in the study protocol.
            • Coordinates study-setup
            • Screens EMR routinely for potential study patients
            • Maintains screening records and patient accruals in CREDIT database
            • Performs data management activities for clinical trials
              • Gathers and verifies source documents.
              • Abstracts and submits accurate data as requested.
              • Verifies the accuracy, completeness and timely submission of case report forms.
              • Corrects and resubmits data or answers queries within a timely manner per the study sponsors guidelines.
              • Utilizes computer software to collate and report abstracted data elements.
              • Maintains a record keeping system that documents patients/participants registered on research studies, their protocol status, copies of the informed consent, and the data submitted.
              • Review patient records for identification of potential adverse events or protocol deviations.
              • Redacts all patient documents and imaging data prior to submission to research bases
              • Reviews and prepares charts for audits
              • Serves as a liaison to research base auditors and pharma monitors
              • Maintains investigational drug (IND) inventory
                • Reviews protocols and assesses current inventory of IND.
                • Orders INDs from Pharmaceutical Management Branch at National Cancer Institute or trial sponsor.
                • Maintains inventory on individual drug accountability records.
                • Ensures treatment order is correct by reviewing protocol guidelines and calculating dose prescribed.
                • Assesses each IND for expiration dates and follows protocol and department guidelines for drug destruction.
                • Order and track laboratory kits needed for research related blood draws. Process and ship specimens as required by protocol. Maintain hazardous materials education certification.
                  • Demonstrates clinical competency by providing direct patient care as required by protocol (EKGs, vitals, lab draws). Obtains protocol specific training as required to enroll patients on clinical trials.
                  • Performs protocol reviews prior to implementation and stays current on protocol amendments
                  • Serves as a professional resource regarding clinical trials, protocol procedures and protocol compliance for investigators, nurses, pharmacists, pathologist, radiologists and other health care personnel.
                  • Trains new study coordinators on job duties/functions and assesses competence
                  • Attends cancer conference to provide information about current protocol availability for presented cases.
                  • Attends NCI research base meetings for updates on clinical trials
                  • Attends Investigator Meetings.
                  • Attends educational workshops and / or conferences as time allows when requested.
                  • Participates in activities such as continuing education, community work, and quality improvement to promote professional development.
                  • Demonstrates a knowledge and compliance with GCP guidelines in the conduction of clinical research.
                  • Performs other duties as assigned.

Keywords: Memorial Health, Decatur , Clinical Research Coordinator, Healthcare , Decatur, Illinois

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