Registered Nurse - Clinical Research

Benefits

Qualifications

• •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
• •Statement of investigator (device trials)
• •CV and medical license for PI and Sub Investigators (SI)
• •Prepare for study site initiation visit
• •Develop study schedule and required procedures, timelines, and deadlines with study patient and family,
• •history review as required per protocol and as ordered by the PI/Sub-I,
• •Obtain required biological specimens from patient, i.e., urine, sputum, etc
• •Administer study specific scales; i.e. stroke scales, mental assessments, etc
• •Administer questionnaires to be completed by the patient, i.e
• •etc., and review for completeness
• •Ensure appropriate study medication or device is ordered for procedure
• •Transport study medication or device to appropriate location
• •Review intra operative inclusion/exclusion criteria
• •Access to information is based on a “need to know” and is the minimum necessary to properly perform assigned duties
• •Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose
• •13 more items(s)

Responsibilities

• •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
• •Attend site pre-study visit/qualification visit meetings and Site Initiation Meeting, whether on site or remote
• •Attend Investigator Meeting either remote or at location specified by the study sponsor (requires travel)
• •Complete and submit new protocol feasibility questionnaires with research site information
• •Review confidentiality forms in conjunction with the ORA and obtain appropriate signatures
• •Assist in study feasibility assessments by considering the patient population, time and personnel
• •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
• •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
• •Financial Disclosure forms for PI and Sub Investigators (SI)
• •IATA training certificates (if applicable for the study)
• •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
• •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
• •Schedule visit and all required personnel (PI, sub-investigators, coordinators, research
• •manager, pharmacy, clinical nursing units, operating room staff, etc.)
• •Schedule study specific training visits,
• •Ensure all study required items are on-site (tablets for questionnaires, lab supplies, devices,
• •study medication/investigational products, EKG machine, etc.)
• •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
• •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
• •Submit the new protocol IRB submission to the ORA through the InfoEd portal and after approval submit
• •to the either WCG through Connexus Portal or approved IRB of record
• •Prepare and submit annual continuing review reports and site termination report to the IRB of record
• •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
• •Prepare and submit protocol deviations and/or violations to the study sponsor and IRB as necessary
• •Patient Interactions
• •Participate in or conduct the informed consent process and HIPAA authorization, per AMC SOP,
• •and answering any questions
• •Obtain the appropriate signatures and dates/time on the ICF form and
• •documents the process and file a copy in the patient’s medical record
• •Assures that patients sign any future
• •amended versions of the consent if applicable
• •Coordinate patient follow-up study visits, treatments, testing, procedures, and schedules
• •Conduct patient study visits and required assessments per each individual protocol
• •Assess patients for eligibility using the study specific inclusion and exclusion criteria
• •Perform patient health assessments to include but not limited to: Vital signs, EKG, medication and medical
• •Perform blood draw to obtain blood specimens
• •Perform POC testing as applicable per SOP, i.e. urine pregnancy, urine drug test, blood sugar, urinalysis
• •Coordinate/schedule other study required procedures to be done, i.e. physical exam with study provider,
• •radiology, ultrasounds, echocardiograms, follow up study visits etc
• •Dispense to patient and train patient on completion of study diary, if applicable
• •Review completed patient diaries with patient
• •In conjunction with the provider, provide oral study mediation to the patient or set up/schedule
• •medication infusions or coordinate with nurse to administer study medication injection
• •Review oral study medication compliance with patient at each visit
• •Collect required data from the patient
• •Procedure Visit –Clinic procedure room, Operating room, Cath lab, Angio suite, etc
• •Ensure appropriate study personnel are scheduled and present for procedure
• •Randomize patient to treatment arm, if required
• •Ensure study procedure requirements are followed
• •Collect specimens as appropriate and send to sponsor as required
• •Monitor and communicate on a continuous basis with patients and families to facilitate identification of
• •untoward side effects/adverse events and initiate and coordinate clinical care to manage and minimize
• •Reasonable efforts, consistent with Albany Med Center policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification
• •68 more items(s)