RN - Clinical Research Nurse

Department/Unit:Emergency Medicine GeneralWork Shift:Day (United States of America)Salary Range:$78,773.63 - $122,099.12The Clinical Research RN is expected to provide organizational and management support for multiple clinical trials and other studies. The position is accountable for assisting in the timely and accurate conduct of research studies, from initiation to completion of study, with an emphasis on flexibility that priorities certain studies depending on the current needs of the research division of the Department of Emergency medicine.The Clinical Research RN works 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.Responsibilities and Duties include:Complete and submit protocol specific research site information, conflict of interest, financial disclosure, and confidentiality forms as appropriateDetermine feasibility of study considering, appropriateness for patient population, maintenance of subject safety and confidentiality, fiscal soundness, and logistical capabilities as appropriateKnowledgeable on each protocol’s specific inclusion, exclusion, therapy, clinical monitoring oversight, laboratory evaluation, safety monitoring and data management requirementsCommunicate and interact with PI, research team, sponsor, IRB, WIRB, Research Administration, appropriate AMC departments (compliance, finance, faculty practice, pharmacy, radiology, laboratory medicine etc.) as appropriateCommunicate and interact with NIH/NCI cooperative groups, pharmaceutical companies, clinical research organizations (CRO’s), and site research organizations (SRO’s) as appropriatePrepare site for initiation of study by coordinating initiation and training site visits, and preparing documents, clinical units, administrative space and personnel for the study as appropriatePrepare and submit forms to establish research cost center - Departmental signature forms, Compliance checklist, Subject budget form, and Unrelated Income tax formPrepare and submit forms to establish G99 research billing accounts with PBS and MCPGPrepare AMCH and AMC Practice Research Patient Registration formsComply with all regulatory agency requirements and protocol guidelines in implementing clinical trialsComplete mandated protocol training – electronic case report system, study specific equipment, study specific point of care testing, and scales/scoring.Develop original source data documentsCoordinate and conduct recruitment efforts, in-service education and screening programsPrepare and coordinate advertisement and media coverage efforts with appropriate AMC departmentsConduct informed consent process; obtain consent and HIPAA authorizationRegister patient as study subject with sponsorCreate and maintain subject screening and enrolment logs, delegation of duty logs, adverse event logsContact sponsor randomization system or request AMCH pharmacy to randomize subject as appropriateCoordinate and conduct screening visits, develop study schedule, timelines, and deadlines with study patient/family, the PI and research team.Perform health assessment procedures as required by the protocol and as ordered by the PI (e.g., EKG, urinalysis, urine pregnancy testing, vital signs, obtain specimens etc.)Administer/perform study scales and questionnairesPerform patient navigation, which includes but is not limited to:  identifying patients who screen positive on various tests; scheduling patients for followup; reminding patients about their appointments; confirming that patients went to their followup appointment; and providing education to patients.Coordinate and work with AMCH and AMC Faculty Practice registration staff to schedule follow-up study visits, treatments, testing and procedures appointmentsCoordinate dispensing of study therapy through the AMCH pharmacy as appropriateEnsure safety of study specific medical equipment used with research subjects, (e.g. EKG machine) via referral to Clinical Engineering; is prepared for emergencies, equipment failure, user errors and reports such events to management.Complete and maintain accurate source data documentationCommunicate on a continuous basis with subjects and families to monitor for adverse effectsEnsures safety of subjects in the case of adverse and serious adverse events, recognizing the difference between the two, documenting events, and reporting appropriately to sponsor, IRB and FDA.Prepare and maintain accurate and complete source documentation and reports on unexpected and serious adverse study related event reports for submission to the sponsor/FDA and IRB, as required by the protocol and federal regulationsProtect subject confidentiality by assuring compliance with federal regulations and guidelines regarding confidentiality in storage, release of information and disposal of records.Plan, prepare for and coordinate monitor site, pharmacy, audit and study termination visitsObtain, process, store and ship clinical laboratory specimens per protocol and in compliance with IATA regulationsExtract information from source documents and complete paper-based and electronic protocol case report forms; maintain data integrity.Review study data for completeness, accuracy and compliance with protocol requirementsSubmit case report forms, subject logs, adverse event logs, query responses and protocol status reports to sponsors in compliance with the individual protocol design. Prepare and submit Progress Reports, Annual Continuing Reviews, SUSAR reports, SAE reports, Unexpected Adverse Event reports to IRB of recordCoordinate secure maintenance and storage of all source and study documents, supplies and study equipment.Prepare invoices for sponsor payment per contract budgetOn a monthly basis, prepare requisitions for payment of AMCH/PBS and AMC Faculty Practice/MCPG research servicesCoordinate study closure per protocol, IRB and regulatory agency guidelines, ensuring subject safety, preparing all necessary paperwork and summaries, returning unused supplies, complying with audits, and responding to any post study correspondence.At all times throughout the study, collaborate with the PI for the protection of human subjects in all the above noted manner and always follow FDA, OHRP and GCP regulations and ICH guidelines and institutional policies and procedures.At all times throughout the study, coordinate the subject’s health care in the interest of the patient firstQualifications:Associate's degree in nursing and active NYS Registered Nurse licensure is required Minimum of five years of research or clinical experience; prefer two-three years’ experienceSpecialized Training, certifications or skills:Possess or successfully complete Human Subjects Protection training certificationPossess or successfully complete Shipping of Dangerous Goods certificationSuccessfully complete institutional credentialing as required: phlebotomy, ekg, CLIA’s, cpr etc.Self-disciplined with excellent organization skills essentialMust be reliable and possess excellent communication skills for all age levelsMust be flexible to prioritize studies that the Vice Chair of Research or the Research Director deems a priority.Establish a good working rapport with study patients, professional staff, department, institution, and sponsors, and be able to work as a team memberAbility to work a flexible schedule to meet the needs of the research protocol visit, treatment and testing schedules as well as travel.Familiarity with office equipment (faxes, copiers, phones) and personal computers skills including word processing, excel spreadsheet and database skills.Thank you for your interest in Albany Med Health System!​Albany Med Health System is an equal opportunity employer.This role may require access to information considered sensitive to Albany Med Health System, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that: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. Reasonable efforts, consistent with Albany Med Health System policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.

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