Regulatory Coordinator - Military Veterans
at HERC- Upper MidWest
Regulatory Coordinator
Title: Regulatory Coordinator
Location: Upper East Side
Org Unit: Infectious Diseases
Work Days: Monday-Friday
Weekly Hours: 35.00
Exemption Status: Non-Exempt
Salary Range: $30.77 - $35.60
*As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices
Position Summary
Oversees the clinical trial regulatory maintenance from study submission through closeout.
Job Responsibilities
- Coordinates all aspects of protocol submission for research projects. Prepares and submits all necessary documents to the Clinical Science Evaluation Committee (CSEC), the Institutional Review Board (IRB) and ancillary committees.
- Works with the research team to facilitate the enrollment of research subjects in compliance with established regulations and guidelines.
- Reviews and confirms subject eligibility and regulatory compliance for enrollment. Submits eligibility exceptions to the IRB.
- Performs central subject registration for specified research studies.
- Reports all Serious Adverse Events (SAEs) to Institutional Review Board and other agencies, as required.
- Ensures maintenance of up-to-date regulatory records and compliance with industry deadlines.
- Coordinates site visits and audits of clinical trials.
- Maintains and disseminates accurate listings of active and potential studies to participating investigators.
- Provides assistance for specified investigator-initiated trials.
- Serves as the resource for detailed information on assigned protocols and other investigational research activities.
- Attends conferences regarding clinical trials and disseminates information to clinical staff.
- Maintains electronic and hard copy files.
- Bachelor's Degree in related field
Approximately one year of prior clinical research experience in a healthcare setting.
Bachelor's degree can be considered in lieu of experience.
Demonstrated knowledge and understanding of clinical research.
Knowledge, Skills and Abilities
- Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise 'people skills'.
- Demonstrated proficiency with MS Office Suite and database applications.
- Demonstrated organizational skills and ability to pay close attention to detail.
- Demonstrated critical thinking and analytical skills.
- Demonstrated ability to multi-task and prioritize in a fast-paced environment.
- Demonstrated ability to remain focused despite frequent interruptions.
- Ability to treat confidential information with utmost discretion.
- Demonstrates ability to exercise standards of professionalism, including appearance, presentation and demeanor.
- Demonstrated ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives.
- Working Conditions/Physical Demands
Standard office work
Weill Cornell Medicine is a comprehensive academic medical center that is committed to excellence in patient care, scientific discovery, and the education of future physicians and scientists in New York City and around the world. Our doctors and scientists - faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician Organization - are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U.S. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey. Our medical practices serve communities throughout New York City, and our faculty provide comprehensive care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian/Lower Manhattan Hospital, NewYork-Presbyterian Hospital/Brooklyn Methodist Hospital, NewYork-Presbyterian Hospital/Westchester Behavioral Health Center, and NewYork-Presbyterian/Queens. At Weill Cornell Medicine, we work together to treat each individual, not just their conditions or illnesses, as we strive to deliver the finest possible care for our patients - the center of everything we do. Weill Cornell Medicine is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to protected status, including race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.
To apply, visit https://jobs.weill.cornell.edu/NY/job/New-York-Regulatory-Coordinator-NY-10065/1241695500/
Copyright 2024 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency
jeid-92730e53f98d4848b1d623d30a45badd
New York, NY
The Higher Education Recruitment Consortium (HERC) is a national nonprofit network of higher education and affiliated employers, committed to institutional collaboration, creating diverse workplaces, and assisting dual career couples. Searching for a job in higher ed? Our job board hosts over 30,000 faculty and staff jobs at workplaces that value diversity, equity, and inclusion. Set up your job seeker account today at: http://www.hercjobs.org For our member institutions, we offer recruitment and retention resources, vibrant regional networks, and a new online community of practice, HERConnect. All of our resources can help you advance inclusive excellence at your institution.