Clinical Research Coordinator

Family Health Centers at NYU Langone, a designated Level 3 Medical Home, is the largest federally qualified health center network in New York State, and the second largest in the nation. It includes eight primary care sites, 40 school-based health centers and dental clinics, four day care centers, the nation's largest dental residency program, and New York State's largest behavioral health program. The network also includes 12 community medicine sites providing care to disenfranchised New Yorkers, comprehensive HIV services, chemical dependency programs, and a family support center that offers educational, vocational, and other social support programs. At NYU Langone Health, equity 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 inclusion and individual skills, ideas, and knowledge.

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

In this role, the successful candidate The Clinical Research Coordinator (CRC) is an active participant of all related clinical research studies from research planning to completion of all studies including direct involvement in case management of study participants, study coordination and data collection. The CRC Works independently under the general supervision of the Principal Investigator, research nurses and/or other research department management to ensure compliance in the conduct of the study, and adherence to the study protocol.

Job Responsibilities:

1. Adhere to the IRB approved protocol and coordinate protocol related research procedures, study visits, and follow-up care ensuring the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and all required obligations to patient/subject, Principal Investigator, Research Team and sponsor and other appropriate agencies.
2. Participates in pre-screening and recruitment activities to identify patients that may be eligible for a clinical trial.
3. Assists patients in understanding the schedule of assessments according to the approved protocol, coordination of appointments, and ancillary services.
4. Write research notes in EPIC for specified visits as outlined by the protocol.
5. Schedule participants according to the approved protocol; coordinate with ancillary service providers to ensure patients remain adherent to the protocol.
6. Work with licensed clinicians to develop tracking forms for all active trials, maintain tracking forms throughout the life cycle of the protocol.
7. Helps compile enrollment packet materials to be reviewed and signed by investigator.
8. Prepare for study visits: research ticket preparation, lab and EKG orders, scheduling of biopsies and scans, facilitating RECIST form, AE and Conmed form completion in conjunction with licensed professional and other tasks as needed.
9. Act as primary point of contact for all bio-specimen collections and at times participate in the collection, processing, and shipment of laboratory specimens, as per protocol.
10. Under the supervision of investigator, assist with the identification, review and reporting of adverse events/serious adverse events/reportable events, protocol deviations, and other unanticipated problems as appropriate.
11. Participate in collection and documentation of Con Meds to be verified and signed by licensed clinicians before submission.
12. Maintain follow up calendar ensuring all survival follow up assessments are completed per the protocol; performs assessments not requiring licensure.
13. May perform EKGs and/or phlebotomy with documented training.
14. Under the supervision of licensed clinicians administers ancillary assessments (i.e., Quality of Life questionnaires) and other assessments as approved by PI and study.
15. Works with nurse and PI to review, compile, and submit weekly pharmacy lists to investigational pharmacy.

Job Responsibilities (Data/Regulatory):

1. As applicable, oversee the submission of necessary documents required by the NYU Institutional Board (IRB), and any other appropriate parties in order to obtain approval to conduct human subjects' research.
2. Participate in coordination/preparation and submission of progress reports.
3. Assist in reconciliation of any clinical discrepancies in data systems.
4. Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities.
5. Coordinate with materials/equipment management to ensure safety of study equipment and monitoring of current inspection stickers when applicable. Coordinates with Sponsor when applicable.
6. Responsible for tracking site reimbursement and allocating patient stipends/compensation.
7. Preparation and maintenance of study, subject and regulatory binders/files.

Additional Duties as Assigned:

1. Assist with study feasibility review and complexity assessment for new protocols (which may include census review of patient population of interest, staff qualifications/schedule review, facilities evaluation, etc.)
2. Assist with budget development, assessment and submission.
3. Participate in scientific publications.
4. Function as a liaison between investigators, OSR, sponsoring agencies, regulatory agencies, other research sites (when applicable), other departments, etc.

Minimum Qualifications:
To qualify you must have a Clinical Research Coordinator: EDUCATION/EXPERIENCE/SKILLS:
i. Associate Degree Required, 2 years relevant experience OR Bachelor's Degree and 1 years experience in research or related healthcare setting.
ii. Computer literate with good interpersonal, oral, writing and verbal communication skills.
iii. Ability to identify, analyze and solve problems, ability to time manage and work well under pressure.
iv. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications.

Preferred Qualifications:
i. Intermediate competency in medical terminology, and an advanced competency in Good Clinical Understanding of (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research.
ii. Professional certification (ACRP CCRC or SOCRA CCRP).
iii. 2-3 years experience in research or related experience preferred.

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

NYU Langone Hospital-Brooklyn 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.

At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family.

NYU Langone Hospital-Brooklyn is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online.

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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 $64,350.00 - $66,144.00 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.

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