Central Services Coordinator JR

1 month ago


Irving, United States ALLIANCE CLINICAL LLC Full time
Job DescriptionJob Description

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  1. Comply with all company policies, procedures, and conduct.
  2. Strictly adhere to confidentiality and compliance standards.
  3. Virtually communicate effectively and courteously with study patients via tele-health platform.
  4. Demonstrate a caring and pleasant demeanor toward patients and their families.
  5. Acknowledge study patients' needs and tend to them appropriately.
  6. Collects patient medical history and conditions.
  7. Conduct study visits across all sites via tele-health platform.
  8. Ensure Informed Consents are obtained by on-site staff.
  9. Participant study visit review and completion.
  10. Ensure data quality.
  11. Collect and evaluate medical records for compliance.
  12. Conduct A/E and SAE assessments.
  13. Maintain and update regulatory files.
  14. Verify accuracy of data collected.
  15. Review study e-source documents to comply with study protocol.
  16. Manage all required study documentation, training, and timelines on assigned study protocols.
  17. Participate in CRO/Sponsor/Audit interactions.
  18. Other tasks and responsibilities as requested to facilitate business needs.

QUALIFICATION REQUIREMENTS: 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and EXPERIENCE:

  1. Some college level courses or related field, preferred.
  2. 0-2 years experience in healthcare, required.
  3. 2 years experience working in Clinical Research, required.
  4. 2 years experience in FDA regulations and GCP.
  5. Comprehensive knowledge of FDA, GCP and HIPAA as applied to clinical research.
  6. Knowledge of current studies being conducted.
  7. Comprehensive knowledge of company's SOPs, policies and Confidentiality agreements.
  8. Knowledge of safety hazards and procedures that establish a safe work environment.
  9. Skilled in computer and data collection software
  10. Excellent customer service skills with internal and external stakeholders.
  11. A proven ability to multi-task in a rapidly changing environment.


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