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Clinical Research Clinical Coordinator

Charlotte Gastroenterology & Hepatology   Charlotte, NC   Full-time     Health Care Provider
Posted on September 25, 2020

This position is responsible for carrying out clinical research activities in accordance with Good Clinical Practice (GCP).  This positions primary concern is the protection and care of the patient as a study subject.

ESSENTIAL FUNCTIONS:

  1. Administrative: 
    1. Attend and participate in Clinical Research Meetings, and other regional or national research meetings.. 
    2. Review research journals and pertinent publications.  
    3. Developing/maintaining standard operating procedures, QA/QC standards to ensure compliance with industry standards.
  2. Site Preparation:
    1. Schedule and coordinate pre-study site visit.  
    2. Preparation of regulatory documents for Sponsor (e.g., 1572, CV, IRB membership, lab-related documents, etc.)
    3. Preparation and submission of IRB documents (e.g., informed consent, advertisements, protocols, etc.)
    4. Prepare space for study-related equipment and supplies.
    5. Present clinical trial time lines to study teams (e.g., enrollment, completion, advertising, schedules, etc.)
    6. Educate staff regarding scientific aspects of the study.
    7. Train/educate ancillary staff regarding clinical trials.
    8. Coordinate study initiation.
  3. Study Conduct:
    1. Perform subject interviews and assessments at study visits as required by protocol.
    2. Monitor study team compliance with required study procedures and GCP/ICH standards.
    3. Assess and ensure subject safety throughout participation in trial. 
    4. Maintain patient and study confidentiality at all times.
    5. Develop appropriate patient education tools to ensure patient understanding and compliance. 
  4. Recruitment
    1. Screen medical records, interview and schedule visits for potential subjects.
    2. Prepare/place advertisements and prepare screening sheets/logs as needed.
    3. Utilize computer-generated diagnosis (ICD-9).
    4. Monitor enrollment goals and modify recruitment strategies as needed.
    5. Explain concept of clinical research and provide patient teaching on disease entity.
  5. Screening:
    1. Review and obtain medical histories, demographics, etc.
    2. Obtain other pertinent medical records as required.
    3. Provide adequate documentation in medical records of screening attempts and conversations.
  6. Scheduling of Patients:
    1. Coordinate subject’s visits as per protocol and with other support services (e.g., physician, ancillary services, etc.)
    2. Call or send reminders of scheduled visits as needed.
  7. Informed Consent:
    1. Explain study to subjects (e.g., purpose, duration, risks/benefits, etc.)
    2. Obtain all required signatures.
    3. Provide subject with copy of signed informed consent.
    4. Document obtaining informed consent in medical records.
  8. Case Report Forms:
    1. Review inclusion/exclusion criteria, document concomitant medications, and review medical history. 
    2. Enter data for specific visit on CRF or with Remote Data Entry (if applicable).
    3. Audit for accuracy and correct CRF’s.
    4. Transmit data by fax, express mail, etc.
    5. Complete and return Sponsor queries promptly.
  9. Source Documentation:
    1. Develop and/or maintain study specific progress note for documentation of study visits.
    2. Incorporate applicable historical documents (e.g., X-ray, pathology, EKG, laboratory, etc.)
    3. Maintain status reports and subject logs.
    4. Document written and verbal communication with study contacts (e.g., subject, Sponsor, IRB, laboratory, etc.)
    5. Schedule and prepare for monitoring visits or audits.
    6. Record and document protocol deviations.
    7. Maintain communications with the IRB with regard to initial submission, annual/quarterly updates, adverse events, safety reports, protocol amendments, informed consent, modifications, changes in personnel or site locations, etc.)
  10. Test Article Accountability:
    1. Store test article supplies in accordance to FDA and Sponsor guidelines.
    2. Receive, inventory, and maintain test article at site.
    3. Dispense and retrieve test articles according to protocol.
    4. Order supplemental test articles and supplies as needed.
    5. Return used and unused test articles to Sponsor or designee.
    6. Maintain randomization and emergency codes of test article.
    7. Document on accountability log and subject medical records.
    8. Manage DEA controlled drugs, if applicable.
  11. Laboratory Issues:
    1. Ensure proper collection, processing, and shipment of specimens (centrifuge, preparation of slides, freezing, refrigeration, etc.)
    2. Utilize or develop procedure and collection forms for pharmakinetic collection and storage.
    3. Communicate with laboratory, physician, and Sponsor regarding laboratory findings. 
    4. Maintain OSHA standards.
    5. Maintain supply inventory.
    6. Maintain equipment (e.g., calibration and preventative maintenance).
    7. Recognize common laboratory values and alerts.
    8. Assure current laboratory certification and normal ranges are provided.
    9. Complete and maintain Hazardous Materials Transport Training.
  12. Adverse Events:
    1. Apply pharmacological Knowledge and utilize reference manuals to assist the Investigator in determining idiosyncrasies, casualty, expected or unexpected results.
    2. Observe, query, and document medical events.
    3. Present Investigator with relevant information for determination of seriousness, casualty, and intervention.
    4. Act on Investigator recommendation for adverse event.
    5. Maintain follow-up to determine resolution of adverse event.
    6. Report serious adverse events to Sponsor and IRB.
    7. Assist Investigator in classifying adverse events (e.g., serious, sever, moderate, mild, expected, unexpected).
    8. Record adverse events and relevant information in source document, CRF, and Sponsor specific forms).
  13. Close-out:
    1. Schedule and prepare for close-out visit.
    2. Return or dispose of unused supplies per Sponsor requirements.
    3. Reconcile test article accountability.
    4. Audit documents and pertinent files and prepare for storage.
    5. Maintain documents as required by FDA/Sponsor guidelines.
    6. Prepare study summary for Sponsor.
    7. Provide method of document retrieval from storage.
    8. Document drop-outs (e.g., causes, contact efforts).
    9. Prepare for and respond to Sponsor and FDA audits.

 

EDUCATION:  RN graduate from accredited school of nursing, LPN graduate from accredited school of nursing, Medical Asst/Medical Technologist, or Certified Clinical Research Coordinator.

EXPERIENCE:  Must have experience with clinical trials.

CERTIFICATES AND LICENSES:  Current certifications by appropriate licensing board as well as CPR/BLS certified.

QUALIFICATIONS (Knowledge, Skills, and Abilities):  The job holder must demonstrate current competencies applicable to job position including but not limited to:

  1. Good understanding of medical terminology.
  2. Professional attitude and appearance.
  3. Strong attention to detail.
  4. Strong self discipline with good interpersonal and organizational skills.
  5. Ability to function and perform job duties without immediate or constant supervision.
  6. Must have medical skill including
    1. Venipuncture
    2. EKGs
    3. Basic laboratory analysis
    4. Injections
    5. Assisting with physical examinations and procedures