Required Qualifications: (As evidenced by an attached resume)Bachelor's Degree (foreign equivalent or higher). One year of full-time related research experience. Must have, keep and maintain the appropriate valid NYS Driver's License; have a motor vehicle record which is free from major violations or a pattern of repeat violations.
(***Out-of-State Applicants, see Special Notes ).Preferred Qualifications:Experience with centralized recruiting databases such as REDCAP. Proficient in word processing, spreadsheets, and database software. Experience with perioperative workflow. Experience conducting industry-sponsored clinical studies. Experience conducting investigator-initiated clinical studies.
Brief Description of Duties: The Clinical Research Associate I will be responsible for educating potential participants about the study, facilitating local and IRB regulatory amendments, annual reviews and reporting and keeping records and data QA/QC up to date. This position entails working some early morning or evening hours.Duties:
- Approach and discuss the study protocols in various setting.
- Educate potential participants about the study and obtain informed consent under minimal supervision of the investigator.
- Follow up with patients as necessary.
- Engage hospital stakeholders in studies and effectively work around existing hospital workflows; assist in the development of recruitment and retention strategies for participant enrollment.
- Train study team members on necessary protocol elements and workflow.
- Maintain relations and correspondence with outside parties.
- Pre-screen records, data entry (pre- and post-interaction) and data QA/QC, Inputting data into centralized recruiting database.
- Facilitate local and IRB regulatory amendments, annual reviews and reporting.
- Handle investigational substances as required.
- Exhibits technical and functional expertise in the area of research through the development of protocols, hypotheses and educational curricula.
- Coordinates daily activities of a designated study or group of studies and maintains industry relationships.
- Guides training of faculty physicians, residents, medical students and research staff on good clinical practice, external regulatory agency requirements.
- Develops scientific protocols and generates hypotheses for research inquiries independently and in collaboration with faculty and trainees; provides technical and functional expertise in the area of research studies.
- Oversees the administration of assessments as assigned and as related to study protocol.
- Collects data, confers with PI and forwards results to sponsor (internal or external).
- Oversees clinical research staff performing clinical functions i.e. ECGs, monitoring vital signs on study participants, etc., when warranted; educates family and contributes to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria.
- Liaises with agencies, pharmaceutical companies, laboratories, and equipment and supply companies as needed; oversees availability of supplies and/or equipment for studies.
- Operates under limited guidance and work assignments involve moderately complex to complex issues where the analysis of situations or data requires in-depth evaluation of variable factors.
- May be required to work outside of regularly scheduled hours on nights and/or weekends.
- 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 Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.***Out-of-State Applicants: Please note as a condition of employment and in order for this position to be tendered, the successful incumbent will be required to provide evidence of a valid license and driving abstract from the state issuing the license within five business days of a conditional offer and must obtain a NYS driver's license within 30 days of start date.For this position, we are unable to sponsor candidates for work visas.This role will require travel between satellite locations, at times, multiple sites in a day.
Evening and weekend work will be required at times.Resume/CV and cover letter should be included with the online application.
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at (631) ###-#### or visit OEA.In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here.Visit our
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SUNY Research Foundation: A Great Place to Work.The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.