Clinical Research Nurse 2
Location: New Haven Connecticut
Description: Yale University is looking of Clinical Research Nurse 2 right now, this position will be placed in Connecticut. Further informations about this position opportunity please read the description below. Reporting to the Manager and Lead Quality Assurance Auditor for Yale Center for Clinical Investigation (YCCI), the position conducts clinical research monitoring and quality improvement effor! ts for clinical trials conducted at the Yale Medical School. This includes involvement in a study from the pre-award stage through the lifecycle of the study once awarded.
Duties
- Consult to investigators needing data safety monitoring plan details/information for their grant applications.
- Assess the risk and stratify the study from a QA/regulatory compliance perspective based on clinical research experience and medical knowledge.
- Write Data and Safety Monitoring Plans based on the risk assignment categories.
- Review medical records of study participants, determine the impact of medical issues (e.g., drugs, effects, etc) on study plans/processes, make judgments and communicate findings to investigators. Exercise judgment in the assessment of the level of risk associated with findings in terms of the need for reporting out to other regulatory entities.
- Conduct ongoing internal QA reviews based on the monitoring plan/schedule! determined for each study.
- Report QA findings relate! d to deviations, non-compliance based on very strict reporting regulations.
- Review reports/findings from audits with investigator and draft and monitor appropriate action plan.
- Conduct follow-up reviews for compliance with audit recommendations, responding to investigator rationale based on clinical knowledge.
- Develop and deliver education and training programs to promote safety and compliance for the PI’s and all study team members.
- Conduct continuous auditing activities identifying areas of high risk and create activity reports for ongoing analysis from a medical standpoint. Interview individuals with specialized knowledge related to an investigation. Identify areas of concern or heightened medical risk to subjects, investigators, or the University.
- Integration of Data Safety and Monitoring Plans and QA findings with committees and educational plans. Department URL Address: Click here for more information Principal Responsibi! lities 1. Evaluates and assesses subject’s suitability for inclusion in studies; develops and modifies procedures according to study findings; recommends changes to the study protocol to coincide with study goals and objectives.
3. Contributes to designing activities, policies and procedures to improve day to day efficiency of the recruitment and assessment components of the study and to ensure that staff members perform activities within established research protocol.
4. Arranges patient enrollment, determines patient eligibility and obtains informed consent.
5. Develops study subject referral sources; designs and develops outreach programs.
6. Collaborates with multidisciplinary researchers to coordinate research programs that integrate new advances in clinical trials.
7. Delegates tasks and supervises the activities of o! ther licensed and unlicensed care providers.
8. May perform other d! uties as assigned. Required Education and Experience Bachelor’s of Science Degree in Nursing and four years of related experience or an equivalent combination of education and experience. Required Skill/Ability 1: Proven hands on research experience and a demonstrated understanding of research protocols. Required Skill/Ability 2: Demonstrated ability to write original reports related to human subject research. Required Skill/Ability 3: Proven understanding of federal regulations governing human subject research and federal reporting. Required Skill/Ability 4: Proficiency with software tools such as Microsoft Word, Access, Excel, Outlook. Required Skill/Ability 5: Proficiency with OnCore and Epic systems. Preferred Education, Experience and Skills: Masters degree in Nursing. Experience in auditing or monitoring of clinical trials. Experience serving on protocol review committees or IRBs. Required Licenses or Certifications Licensure as Registered Nurse in the State of Conn! ecticut or Connecticut license eligible. Weekend Hours Required? Occasional Drug Screen No Health Screening No Background Check Requirements All external candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle and credit checks based on the position description and job requirements. All offers are contingent on successful completion of a background check. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process. Posting Disclaimer The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.
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If you were eligible to this position! , please email us your resume, with salary requirements and a resume to! Yale University.
If you interested on this position just click on the Apply button, you will be redirected to the official website
This position starts available on: Tue, 05 Nov 2013 15:23:37 GMT