- 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 - Prepare and submit regulatory documents required by federal regulations to the Study sponsor/CRO prior to
- Complete the delegation of authority/duty logs to indicate the site personnel involved with the study and
- Prepare the patient informed consent (ICF) and assent (if applicable) by inserting the AMC required language
- Prepare for study site initiation visit
- Develop original source data collection worksheets to comply with protocol specific data requirements to
- Prepare initial
IRB submission documents to include: AMC Checklist,
IRB application, study protocol, ICF, - Submit the new protocol
IRB submission to the ORA through the InfoEd portal and after approval submit - 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 - Prepare and submit protocol deviations and/or violations to the study sponsor and
IRB as necessary - Participate in or conduct the informed consent process and HIPAA authorization, per AMC SOP,
- Develop study schedule and required procedures, timelines, and deadlines with study patient and family,
- 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
- Obtain required biological specimens from patient, i.e., urine, sputum, etc.
- Perform blood draw to obtain blood specimens
- Administer study specific scales; i.e. stroke scales, mental assessments, etc.
- Administer questionnaires to be completed by the patient, i.e. quality of life questionnaires, pain scores,
- 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,
- 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
- 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.
- Monitor and communicate on a continuous basis with patients and families to facilitate identification of
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RN - Clinical Research Nurse - NE - Middletown - Albany Medical Center
Description
Department/Unit:
Emergency Medicine General
Work Shift:
Per Diem (United States of America)
Salary Range:
$78, $122,099.12
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
logistical capabilities including interdepartmental needs, i.e. radiology, operating room, inpatient and
outpatient pharmacy.
committees as appropriate:
Research Pharmacy, Value Analysis (VAMS), Antibiotic Sub-committee, Radiation
Safety Committee, Institutional Biosafety Committee, Departmental Review Committees
a 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 study
f.
IATA training certificates (if applicable for the study)
no longer involved with the study.
IRB submission
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.)
C.
IRB
other patient facing materials
IRB of record.
changes to advertisements of patient facing materials
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.
b. Ensure appropriate study personnel are scheduled and present for procedure
c. Transport study medication or device to appropriate location
d. Review intra operative inclusion/exclusion criteria
e. Randomize patient to treatment arm, if required
f. Collect required data before, during and after the procedure
g. Ensure study procedure requirements are followed
h. Collect specimens as appropriate and send to sponsor as required
harm to research patient
Thank you for your interest in Albany Medical Center
Albany Medical is an equal opportunity employer.
This role may require access to information considered sensitive to Albany Medical Center, 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.
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.
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