8 days old

Clinical Research Coordinator RN

Stormont Vail Health
Topeka, KS 66625
**Summary:**



The Clinical Research Coordinator is responsible the coordination of clinical research protocols. Activities include, but are not limited to: protocol feasibility, subject recruitment, eligibility assessment, informed consent, study-specific procedures, data collection, case report form maintenance, protocol compliance, drug supply inventory, and interactions with physicians, clinical research associates, patients and others. The Clinical Research Coordinator RN promotes Good Clinical Practice in the conduct of clinical investigations by possessing an in-depth knowledge of FDA regulations, human subject protections, and other research regulation requirements.







The delivery of professional nursing care at Stormont-Vail Health _Care_ is guided by _Jean Watsons Theory of Human Caring_ and the theory of Shared governance, both of which are congruent with the mission, vision, and values of the organization. Watsons Caring Theory ensures the development of therapeutic relationships and involves human beings and their spirit in every aspect of care delivery, and is demonstrated through the implementation of ten (10) carative behaviors:







1. attentive listening



2. comforting



3. honesty



4. patience



5. responsibility



6. providing information to allow informed decisions



7. touch



8. sensitivity



9. respect



10. calling the patient by name







**Essential Duties and Responsibilities** **include the following. Other duties may be assigned.**









+ Coordinate the conduct of clinical trials.

+ Coordinate clinical trials, adhering to the protocol and coordinating the research subject through the protocol requirements and schedule.

+ Coordinate subject identification and eligibility activities, including database lists, incoming calls and inquiries, telephone screening, chart reviewing, discussing the protocol with prospective subjects, presenting/re-presenting candidates to principal and sub investigators, and scheduling per protocol requirements.

+ Actively participate in study enrollment goal fulfillment, including: requesting Epic queries and maintaining records of results and chart reviews, organizing all referred patients and PCP communication, organizing all advertising-generated calls, working closely with principal investigator concerning status of enrollment and plans to meet the enrollment goal, communicating frequently with Director about status of enrollment, and other tasks as appropriate.

+ Develop and/or adapt study-specific source documentation.

+ Document subjects relevant medical history, research source documentation, and Epic documentation per Clinical Research Center Standard Operating Procedures (SOPs).

+ Conduct informed consent following the Clinical Research Center SOPs and demonstrate an in depth understanding of the protocol and the ICF document.

+ Manage IVRS/IWRS (interactive voice response systems) and randomization codes per protocol requirements.

+ Manage laboratory requirements of protocol, including requisitions, education of phlebotomy staff, review of results, and coordination with principal and sub investigators per Clinical Research Center SOPs.

+ Coordinate study supply inventories, including ordering and documentation.

+ Complete required log as required by sponsor and department, such as protocol-specific Screening & Enrollment logs, Clinical Research Center study summaries, and Subject ID logs.

+ Document and address Adverse Events, IND Safety Letters, and Serious Adverse Events per Clinical Research Center SOPs and sponsor requirements.

+ With the assistance of Clinical Research Center administrative assistants, manage subject reimbursement requirements.

+ Manage drug accountability for assigned protocols, complying with the Clinical Research Center SOPs and sponsor requirements.

+ Manage case report form reporting and other data collection, complying with the Clinical Research Center SOPs and sponsor requirements.

+ Maintain protocol regulatory binders, complying with the Clinical Research Center SOPs.

+ Manage IRB communication, complying with the Clinical Research Center SOP.

+ Manage monitor visits, including scheduling and follow-up.

+ Manage protocol queries per Clinical Research Center SOPs and sponsor requirements.

+ Manage documentation and organization of un-blinding processes.

+ Manage protocol amendments per Clinical Research Center SOPs and by using following the Amendment Flow Sheet.

+ Manage study close-outs activities per sponsor requirements, using the Clinical Research Center Study Close-out Checklist.

+ Participate in protocol planning meetings as assigned.

+ Attend protocol-specific and industry meetings as assigned.



+ Prepare and administer IV investigational products as specified by research protocols and in compliance with Clinical Research Center SOPs.



+ Assist with department tasks and responsibilities:

+ Assist with protocol feasibility as assigned.

+ Assist with site screening meetings and tasks as assigned.

+ Assist with study start-up, including: planning, organizing, trouble-shooting, and coordinating activities with SVHC/COC departments for needed protocol procedures, such as radiology, ultrasound, respiratory therapy, endoscopy, etc.

+ Serve as back-up coordinator as assigned.

+ Assist with training other coordinators and department staff as assigned.

+ Assist/comply with quality assurance and process improvement systems per Clinical Research Center SOPs.

+ Assist with marketing projects as needed.

+ Communicate with primary care offices as needed.

+ Establish and maintain computer system knowledge to master electronic data capture, SVHC/COC electronic medical record and scheduling systems, down-loadable training programs, web-based training programs, and other systems as needed.

+ Interact with various clinical research professionals, including monitors, sponsor representatives, CRO representatives - demonstrating professionalism and respect for SVHC/COC and the Clinical Research Center.

+ Participate in department meetings as requested.

+ Participate in community research events, such as health fairs and other health-related events, as assigned.



+ Establish knowledge and expertise about the clinical research field:

+ Study, learn and apply all Food and Drug Administration regulations and guidelines applicable to clinical research.

+ Establish and maintain working knowledge of the Code of Federal Regulations.

+ Establish and maintain working knowledge of International Code of Harmonization.

+ Establish and maintain expert knowledge of SVHC/COC Policies.

+ Establish and maintain expert knowledge of HIPPA guidelines and protect patient/subject personal health information per SVHC/COC guidelines.

+ Establish and maintain expert knowledge of Clinical Research Center Standard Operating Procedures.



+ Maintain SVHC competencies:

+ Maintain SVHC competency on all procedures required for clinical research protocol execution, such as ECG, waived laboratory testing, vital signs, or other protocol-specific procedures.

+ Coordinate, supervise, and engage in direct patient/subject care associated with and during various clinical research protocols, including conducting ECGs, vital signs.

+ Maintain any required training and credentialing.

+ Maintain current curricula vitae.

+ Sign-off on knowledge at time of employment and during annual competencies.







**Qualifications:**



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/Experience:**



Graduate of an accredited school of nursing, BSN preferred. Clinic Research experience preferred.







**Certificates and Licenses:**



Current RN licensure in the State of Kansas and BLS required. Certification from an accredited association of clinical research professionals is preferred.

Categories

Posted: 2020-02-08 Expires: 2020-03-09

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Clinical Research Coordinator RN

Stormont Vail Health
Topeka, KS 66625

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