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Practice Plan UrologyWork Shift:
Day (United States of America)Salary Range:
$51755.37 - $77633.06The 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. in or conduct the informed consent process and HIPAA authorization
2. Develop study schedule and required procedures timelines and deadlines with study patient and family the PI and research team.
3. Coordinate patient study visits treatments testing procedures and schedules
4. Conduct patient study visits and required assessments per 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
7. Obtain required biological specimens from patient i.e. urine tissue specimens etc.
8. Perform blood draw to obtain blood specimens
9. Administer questionnaires to be completed by the patient i.e. quality of life questionnaires pain scores etc. and review for completeness
10. Perform POC testing as applicable per SOP i.e. urine pregnancy urine drug test urinalysis
11. Dispense to patient and train patient on completion of study diary if applicable and review upon return
12. 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
protocol specific required training i.e. electronic case report forms (ECFR) study specific equipment for patient testing/procedures point of care testing questionnaires/scales/ scoring electronic/paper diaries etc.
14. Maintain study regulatory documents binder
15. Recruit and screen potential patients
required temperature logs either through AMC Centrak system or daily monitoring of the temperature via certified min/max thermometers
17. Plan prepare for and coordinate sponsor personnel (monitor) visits for interim monitoring visiting the pharmacy audits protocol training and site termination visits.
18. Obtain process store and ship clinical laboratory specimens per protocol and in compliance with IATA regulations to include blood specimens urine specimen pathology specimens pathology slides etc.
19. Coordinate study closure per protocol and regulatory agency guidelines.
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.
Required Experience:
IC
Full-Time