RN - Clinical Research Nurse - NE

Department / Unit :

Emergency Medicine General

Work Shift :

Per Diem (United States of America)

Salary Range :

$78,773.63 - $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

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 study

f.

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 InfoEd 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 process and file a copy in the patient's medical record. Assures that patients sign any future

amended versions of the consent if applicable.

2. Develop study schedule and required procedures, timelines, and deadlines with study patient and family,

the PI and research team.

3. Coordinate patient follow-up study visits, treatments, testing, procedures, and schedules

4. Conduct patient study visits and required assessments per each individual protocol

5. Assess patients for eligibility using the study specific inclusion and exclusion criteria.

6. Perform patient health assessments to include but not limited to : Vital signs, EKG, medication and medical

history review as required per protocol and as ordered by the PI / Sub-I,

7. Obtain required biological specimens from patient, i.e., urine, sputum, etc.

8. Perform blood draw to obtain blood specimens

9. Administer study specific scales; i.e. stroke scales, mental assessments, etc.

10. Administer questionnaires to be completed by the patient, i.e. quality of life questionnaires, pain scores,

etc., and review for completeness

11. Perform POC testing as applicable per SOP, i.e. urine pregnancy, urine drug test, blood sugar, urinalysis

12. Coordinate / schedule other study required procedures to be done, i.e. physical exam with study provider,

radiology, ultrasounds, echocardiograms, follow up study visits etc.

13. Dispense to patient and train patient on completion of study diary, if applicable

14. Review completed patient diaries with patient

15. 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.

16. Review oral study medication compliance with patient at each visit

17. Collect required data from the patient

18. Procedure Visit -Clinic procedure room, Operating room, Cath lab, Angio suite, etc.

a. Ensure appropriate study medication or device is ordered for procedure

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

19. 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

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. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. 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.