Job Description
Required Qualifications (as evidenced by an attached resume): Bachelor's degree (foreign equivalent or higher). In lieu of a Bachelor's degree, a combination of clinical/healthcare, medical type industry setting and/or human research experience totaling four (4) years full-time may be considered. Two (2) years of full-time research experience. One (1) year of full-time human research experience. Knowledge of medical terminology.
Preferred Qualifications: Experience coordinating clinical trials in Oncology. Previous use of e-regulatory systems and Clinical Trial Management Systems. Direct experience with IRB submissions to BRANY and Stony Brook IRB. Prior experience entering data in REDCap database. Proficiency with Microsoft Word, Excel and/or PowerPoint.
Brief Description of Duties: At Stony Brook Medicine, a Clinical Research Associate is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital. Qualified candidates will demonstrate superior patient care and possess outstanding communication skills while adhering to our high standard of excellence. The successful incumbent will have excellent communication and organizational skills.
Duties: - Prepares and submits protocols and supporting documents to the IRB of record for approval and the local IRB for acknowledgment, including submission of continuations and amendments, as necessary to maintain compliance with NCI requirements, GCP guidelines, and institutional policies. Responds to all questions from the IRB related to the regulatory aspects of the study.
- Creates and maintains files and documentation pertaining to regulatory requirements for clinical trials.
- Obtain consent from research subjects.
- Create research records (e.g. a research binder) for each participant by chart review for the duration of the study, as either physical and/or electronic records.
- Maintain a working knowledge of the research plan, and explain the study procedures and expectations to prospective participants.
- Enter study data in REDCap timely and accurately, and transmit imaging data to sponsor.
- Completion of data case report forms both paper and electronic.
- Document screening, eligibility, data collection, completion of Case Report Forms and all regulatory requirements per protocol.
- Maintain Informed Consent file versions, and other study documentation.
- Ensure appropriate patient follow-up as required by protocol.
- Other duties or projects 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.
For this position, we are unable to sponsor candidates for work visas.
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) 632-6280 or visit OEA.
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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.
Job Tags
Full time, Work at office, Local area, Visa sponsorship, Work visa,