RN - Clinical Research Nurse - NE

Location: City of Albany

Department/Unit:

Emergency Medicine General

Work Shift:

Per Diem (United States of America)
Salary Range:$78,773.63 - $The clinical research coordinator is responsible for the organization and management of multiple industry  sponsored and Investigator initiated clinical trials. The position is accountable for assisting in the timely and   accurate conduct of research studies, being concerned primarily for the protection and care of the patient as a  research patient from initiation to completion of study. Activities include participating in the study start up and  termination procedures, working with study participants in various study tasks including patient recruitment,  screening for eligibility, scheduling, physical assessments and biospecimen collection and processing, as well as  data collection and study completion activities.

The research coordinator serves as the liaison between PI and  research site and the study sponsor and other vendors working on the trial.

B. Pre-Study Initiation  
1. Attend site pre-study visit/qualification visit meetings and Site Initiation Meeting, whether on site or remote    
2. Attend Investigator Meeting either remote or at location specified by the study sponsor (requires travel)     3. Complete and submit new protocol feasibility questionnaires with research site information.
4. Review confidentiality forms in conjunction with the ORA and obtain appropriate signatures   
5. Assist in study feasibility assessments by considering the patient population, time and personnel  requirements, competing trials, ability to maintain patient safety and confidentiality, fiscal soundness, and  logistical capabilities including interdepartmental needs, i.e. radiology, operating room, inpatient and  outpatient pharmacy.
6. Prepare and submit pre-IRB approval documents for review and approval by the following institutional  committees as appropriate:
Research Pharmacy, Value Analysis (VAMS), Antibiotic Sub-committee, Radiation  Safety Committee, Institutional Biosafety Committee, Departmental Review Committees    
7. Prepare and submit regulatory documents required by federal regulations to the Study sponsor/CRO prior to  site initiation and maintain during the course of the study    a. 1572 (pharmaceutical trials)   b. Statement of investigator (device trials)   c. Financial Disclosure forms for PI and Sub Investigators (SI)   d. CV and medical license for PI and Sub Investigators (SI)   e. Current Human Subject Protection and Good Clinical Practice (GCP) training certificates for   all personnel on the studyf.
IATA training certificates (if applicable for the study)    8. Complete the delegation of authority/duty logs to indicate the site personnel involved with the study and  update as necessary throughout the course of the study with either new study personnel or personnel that is  no longer involved with the study.
9. Prepare the patient informed consent (ICF) and assent (if applicable) by inserting the AMC required language  into the sponsors ICF template and submitting to the sponsor for approval prior to IRB submission    10. Prepare for study site initiation visit   a. Schedule visit and all required personnel (PI, sub-investigators, coordinators, research  manager, pharmacy, clinical nursing units, operating room staff, etc.) to be present   b.

Schedule study specific training visits,    c. Ensure all study required items are on-site (tablets for questionnaires, lab supplies, devices,  study medication/investigational products, EKG machine, etc.)11. Develop original source data collection worksheets to comply with protocol specific data requirements to   include adverse event logs, and medication logs to ensure all required patient data is collected.

C.
IRB  1. Prepare initial IRB submission documents to include: AMC Checklist, IRB application, study protocol, ICF,          advertisements, Investigator Brochure, patient diaries (paper or screen shots), patient questionnaires,  other patient facing materials    
2. Submit the new protocol IRB submission to the ORA through the Info Ed portal and after approval submit  to the either WCG through Connexus Portal or approved IRB of record.
3. Prepare and submit annual continuing review reports and site termination report to the IRB of record    
4. Prepare and submit any changes to the IRB approved study documents as requested by the study sponsor  to include protocol amendments, changes to the ICF, new versions of the Investigator Brochure, new or  changes to advertisements of patient facing materials   
5. Prepare and submit protocol deviations and/or violations to the study sponsor and IRB as necessary

D. Patient Interactions  1.
Participate in or conduct the informed consent process and HIPAA authorization, per AMC SOP,   with research participants through discussion of the study protocol, procedures, timelines, risks, benefits  and answering any questions. Obtain the appropriate signatures and dates/time on the ICF form and  documents the…