The primary function of the Research Coordinator is to coordinate and perform all the associated duties associated with coordination and implementation of the conduct of clinical research trials and projects.
1. Assists and conducts literature review, appraisal and grading of evidence and collaborates on proposal development
2. Prepare and submit institutional review board application.
3. Act as a liaison between Institutional Review Board(s) principal investigators, sub-investigators, assuring compliance with regulatory and institutional mandates and regulations inclusive of but not limited to amendments to protocols and/or modifications to study design as appropriate.
4. Reports all serious adverse events to sponsor and IRB(s).
5. Serves as primary study coordinator ensuring adherence to the research protocol and provides periodic updates to Principal Investigator on study progress.
6. Assist in the development of forms, questionnaires, and completes case report forms and maintains source document
7. Creates and maintains regulatory binders and files for assigned protocols
8. Collaborates with the research nurse coordinator in creating source document
9. Screens research subject /participants as delineated in study specific eligibility criteria
10. Obtains informed consent
11. Assures follow-up on all protocol patients by maintaining updated records, reviewing active patient lists for correct and current materials, and co-investigators of diagnostic tests needed for protocol compliance.
12. Performs periodic quality assurance audits to ensure completeness and accuracy of study documents
13. Collects data collection, data validation and verification through and continually monitors to assure investigates and resolves discrepancies.
14. Maintains a thorough knowledge of all aspects of protocol including primary clinical aim, method of protocol execution, budgetary and logistic components and contractual requirements.
15. Must continually seek and attend educational venues related to governmental regulations, research and data management.
16. Identifies the needs of the patient population served and provides service that is specific to those needs (i.e. culture, language, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).
17. Adheres to the standards in the Medical Center's Organizational Competencies.
- Bachelor's degree or equivalent.
- Minimum of 1 year of clinical research/regulatory experience or equivalent.
- Mandatory education on human subject research.
- Strong computer skills
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