Clinical Research Associate I - NYU Langone Medical Center

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity, diversity, and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace diversity, inclusion, and individual skills, ideas, and knowledge. For more information, go tomed.nyu.edu, and interact with us onLinkedIn,Glassdoor,Indeed,Facebook,TwitterandInstagram.

Position Summary:
We have an exciting opportunity to join our team as a Clinical Research Associate I.

In this role, the successful candidate The Clinical Research Associate CRA I will report directly to the Research Project Manager RPM and the Center Director of the Center for Psychedelic Medicine and Principal Investigator PI of an NIH funded multi center clinical trial for opioid use disorder and psychedelics The CRA performs and coordinates all aspects of the clinical site monitoring services assessing for protocol and regulatory compliance The CRA may also be involved in performing periodic QA reviews of the Center for Psychedelic Medicines other investigator initiated clinical trials

Job Responsibilities:

Coordinating center activities

• Develops and executes the studys monitoring plans

• Development of educational materials for site coordinators and staff

• Provides regular updates to the PI and RPM regarding site start up recruitment and enrollment status

• Assist with providing annual updates to NIH FDA DSMB and IRB regarding study progress

Site management

• Conducts site initiation interim and close out visits

• Ensures sites meet performance expectations related to recruitment enrollment and retention

• As per risk based monitoring procedures reviews site source documentation case reports and verifies accurate data capture

• Performs site management activities to ensure compliance to the protocol monitoring plan GCP ICH applicable federal/local regulations and SOPs

• Maintains ongoing communications with site personnel and assists with problem solving during all stages of study start up conduct and close out

• Performs drug accountability reconciliation and destruction Verifies storage and shipment requirements are according to protocol

• Builds and maintains professional relationships with site personnel

• Analyzes issues and uses sound judgment to make decisions and escalates study related issues as necessary

• Travels to clinical study sites as required including remote or onsite visits

Regulatory Oversight

• Maintain Master Regulatory File for the study

• Ensures site regulatory files are current and verifies the timely submission of study documentation including safety reporting

• Review yearly IRB approvals and any modifications in consent for each of the sites

• Ensure that sites maintain the necessary state and federal approval to conduct clinical research with a Schedule 1 substance

Other: Participate in special projects and perform other duties as assigned

Minimum Qualifications:
To qualify you must have a Bachelors degree or equivalent Minimum of 4 years progressively responsible clinical research experience preferably in a research / academic / health care setting Proficiency in using various Microsoft Office applications such as Word Excel Access Power Point and Outlook Effective interpersonal and communications skills verbal and written Ability to work within a team environment as well as independently Ability to interface effectively with all levels of management; must work and communicate effectively with internal and external parties Effective multi tasker and problem solver; detail oriented

Preferred Qualifications:
CCRA certification Knowledge of basic medical terminology Experience working in an Academic Medical Center as a clinical monitor

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents.

NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
If you wish to view NYU Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information.

NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $67,771.14 - $99,546.72 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

To view the Pay Transparency Notice, please click here