Required Qualifications (as evidenced by an attached resume): Bachelor's degree (foreign equivalent or higher). Two (2) years of full- time, progressively responsible experience working on clinical trials. Experience completing web-based case report forms for industry sponsored research. Experience interacting with human subjects and assisting with the participation consent process. Experience with IRB submissions.
Preferred Qualifications: Previous clinical trial experience as it relates to Interventional Cardiology and Structural Heart (Device and Pharmaceutical). Proficiency in Microsoft Office to include Excel, Word and PowerPoint. Current IATA Shipping Certification. Basic Life Support Certification. Completion of the Collaborative Institutional Training Initiative courses:
CITI - (Group 2B Biomedical Researcher)
CITI - CRC (Clinical Research Coordinator)
CITI - GCP (Good Clinical Practice)
CITI - COI (Conflict of Interest)
C.C.R.C. (Certified Clinical Research Coordinator)
Brief Description of Duties: Clinical Research Coordinator for Invasive Cardiology Study Team. Clinical Research Associate I must have excellent organizational and communication skills (both verbal and written). Clinical Research Associate I will be responsible for completing the regulatory requirements in human research and completion of IRB documents.
Recruit, assess, enroll, screen, and schedule patients for eligibility in clinical cardiology research studies. Maintain a database of participants. Review patient medical history to determine if the patient is eligible for the study. Ensure all necessary testing and consents are completed prior to study according to protocol - ensure study compliance with institution and federal guidelines, as required.
Ensure proper patient follow-up according to study protocol. Collect and compile clinical trial or study patient data. Maintain data for sponsor and investigator for research use as well as in presentations and publications. Assist in the preparation of presentation and publications. Develop and revise as necessary clinical research data forms.
Liaison with sponsors, cooperative groups, regulating agencies, clinical departments and departmental staff. Monitor and maintain patient medical records during study. Prepare and distribute appropriate study information to patients.
Ensure all technical, nursing and cardiology staff are educated on protocol of any given research study. Provide progress reports to investigators. Assist investigators with clinical trial related activities.
May assist Principal Investigator with writing grants, grant submissions and renewals.
Travel to investigator meetings and provide updates to sponsors, investigators and IRB.
Other duties as assigned.
Special Notes: The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Nonexempt position, eligible for the overtime provisions of the FLSA.
In accordance with the New York State Department of Health (DOH) regulation that all hospitals and nursing homes "continuously require all personnel to be fully vaccinated against COVID-19," Candidates who are not already vaccinated must obtain the first dose of the vaccine within three (3) calendar days of acceptance of conditional job offer and must obtain any subsequent doses in accordance with the vaccine protocol. Candidates who are partially vaccinated, but not yet fully vaccinated, must complete their vaccination series within three (3) calendar days of job offer or in accordance with vaccine manufacture protocol, whichever comes later.
The regulation also includes those who may be affiliated with or interact with employees of a hospital or nursing home. The regulation allows for limited exemptions with reasonable accommodations, consistent with applicable law.
Resume/CV and cover letter should be included with the online application.
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