RN - Clinical Research Nurse New

Department/Unit:

Emergency Medicine General

Work 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 appropriate

• Determine feasibility of study considering, appropriateness for patient population, maintenance of subject safety and confidentiality, fiscal soundness, and logistical capabilities as appropriate

• Knowledgeable on each protocol’s specific inclusion, exclusion, therapy, clinical monitoring oversight, laboratory evaluation, safety monitoring and data management requirements

• Communicate and interact with PI, research team, sponsor, IRB, WIRB, Research Administration, appropriate AMC departments (compliance, finance, faculty practice, pharmacy, radiology, laboratory medicine etc.) as appropriate

• Communicate and interact with NIH/NCI cooperative groups, pharmaceutical companies, clinical research organizations (CRO’s), and site research organizations (SRO’s) as appropriate

• Prepare 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 appropriate

• Prepare and submit forms to establish research cost center - Departmental signature forms, Compliance checklist, Subject budget form, and Unrelated Income tax form

• Prepare and submit forms to establish G99 research billing accounts with PBS and MCPG

• Prepare AMCH and AMC Practice Research Patient Registration forms

• Comply with all regulatory agency requirements and protocol guidelines in implementing clinical trials

• Complete mandated protocol training – electronic case report system, study specific equipment, study specific point of care testing, and scales/scoring.

• Develop original source data documents

• Coordinate and conduct recruitment efforts, in-service education and screening programs

• Prepare and coordinate advertisement and media coverage efforts with appropriate AMC departments

• Conduct informed consent process; obtain consent and HIPAA authorization

• Register patient as study subject with sponsor

• Create and maintain subject screening and enrolment logs, delegation of duty logs, adverse event logs

• Contact sponsor randomization system or request AMCH pharmacy to randomize subject as appropriate

• Coordinate 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 questionnaires

• Perform 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 appointments

• Coordinate dispensing of study therapy through the AMCH pharmacy as appropriate

• Ensure 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 documentation

• Communicate on a continuous basis with subjects and families to monitor for adverse effects

• Ensures 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 regulations

• Protect 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 visits

• Obtain, process, store and ship clinical laboratory specimens per protocol and in compliance with IATA regulations

• Extract 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 requirements

• Submit 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 record

• Coordinate secure maintenance and storage of all source and study documents, supplies and study equipment.

• Prepare invoices for sponsor payment per contract budget

• On a monthly basis, prepare requisitions for payment of AMCH/PBS and AMC Faculty Practice/MCPG research services

• Coordinate 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 first

Qualifications:

• 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’ experience

Specialized Training, certifications or skills:

• Possess or successfully complete Human Subjects Protection training certification

• Possess or successfully complete Shipping of Dangerous Goods certification

• Successfully complete institutional credentialing as required: phlebotomy, ekg, CLIA’s, cpr etc.

• Self-disciplined with excellent organization skills essential

• Must be reliable and possess excellent communication skills for all age levels

• Must 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 member

• Ability 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.