Since 1875, South Brooklyn Health has established its reputation for clinical excellence and culturally competent care. It has designations as a Certified Percutaneous Coronary Intervention (PCI) Center, an Advanced Primary Stroke Center, an accredited Baby-Friendly Hospital, a U.S. News & World Report high performing hospital. The hospital's staff is as diverse as the patients they serve. Interpreter services can be provided at any time of the day or night in over 130 languages.

At NYC Health + Hospitals, our mission is to deliver high quality care health services, without exception. Every employee takes a person-centered approach that exemplifies the ICARE values (Integrity, Compassion, Accountability, Respect, and Excellence) through empathic communication and partnerships between all persons.

Work Shifts

8:00 A.M - 4:00 P.M

Job Description

Purpose:

To provide research administrative coordination between departments, investigators and subjects with data management, recruitment, clinical visits, regulatory requirements and sponsor/institutional commitments.

Specific Duties and Responsibilities:

Position Description:

Reporting directly to the Director of Research, this person will work closely with Principal Investigators (PI) and study co-investigators (co-I) in the coordination of industry-sponsored and investigator-initiated clinical trials and projects. This person will be responsible for coordinating daily clinical trial activities, and will play a critical role in the conduct and approval of clinical trials within all Departments at SBH. The position requires a high level of organizational skills, analytical skills, and the ability to work independently.

Specific Duties as Related to Clinical Trials:
1. Schedules study subjects' appointments and serves as the patient liaison to the PI and co-Is.
2. Reviews and comprehends clinical trial protocols including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
3. Possess thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during the informed consent process.
4. Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits.
5. Complete and submit case report forms (CRFs) to study sponsors.
6. Responds to data clarification requests from sponsors in a timely manner.
7. Attend industry-sponsored investigator meetings requiring travel( or via Webex) and report pertinent information back to research team members.
8. Coordinate with PIs to ensure that clinical research and related activities are performed in accordance with Federal regulations, Institutional Review Board (IRB) and internal hospital policies and procedures.
9. Maintain subject screening logs and protocol deviation logs.
10. Maintain an Access database of all subjects enrolled on clinical trials.
11. Coordinate and facilitate monitoring and auditing visits.
12. Collaborate with PI to respond to audit findings and implement approved recommendations.
13. Complete documentation on each study visit that is used to track all study related activities.
14. Ensures that all materials for each clinical trial protocol are available for subject enrollment.
15. Performs specimen processing and shipment of biological specimen duties as needed.
16. Assists with study materials including but not limited to, the informed consent document, CRFs, enrollment logs, and drug/device accountability logs.
17. Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
18. Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.
19. Maintain BRANY IRB approvals.
20. Obtain internal study approval through the NYC/H+H "System to Track and Approve Research" ("STAR") program.
21. Assist physicians, nurses, and other research investigators in the research approval process.
22. Other job related duties as required.

Specific duties related to resident-led research:
1. Provide guidance during protocol writing, IRB submission process and STAR submission process.
2. Assist the Director of Research with all tasks related to monthly research meetings and annual research fair.
3. Provide timely communication with all parties conducting research.
4. Keep a database of all resident/fellow led projects by departments and provide an oversight of their activities; monthly report to the Director of research in regards to the status of all IRB-approved projects.ts.

Minimum Qualifications
1. A Masters Degree in Art or Science with a specialization in Hospital Administration, Health Care Administration, Administrative Medicine or in Public Health when conferred for a program in hospital administration from an approved college or university; and,
2. Four years of administrative experience and background at responsible management and administrative levels; or,
3. An equivalent combination of training, educational background and experience in related fields and educational disciplines; and,
4. Knowledge of fundamentals of hospital organization, administration and standards, regulations and laws applicable to hospital operations. Knowledge of principles of business and personnel administration, management functions and support service functions and ability to direct and supervise personnel.

Department Preferences
1. Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
2. Knowledge of medical terminology a plus.
3. Excellent organizational skills to manage work flow independently.
4. Ability to prioritize quickly and appropriately.
5. Ability to multi-task.
6. Meticulous attention to detail
7. Ability to handle highly confidential information.
8. Knowledge of good clinical practice, FDA, OHRP, HIPAA policies.
9. Proficiency in Microsoft Visio, Access, Publisher, Word, Excel, and PowerPoint is a must.
10. Knowledge of fundamentals of hospital organization, administration and standards, regulations and laws applicable to hospital operations. Knowledge of principles of business and personnel administration, management.
11. Experience utilizing Electronic Medical Records.

NYC Health and Hospitals offers a competitive benefits package that includes:

• Comprehensive Health Benefits for employees hired to work 20+ hrs. per week
• Retirement Savings and Pension Plans
• Loan Forgiveness Programs for eligible employees
• Paid Holidays and Vacation in accordance with employees' Collectively bargained contracts
• College tuition discounts and professional development opportunities
• Multiple employee discounts programs

Vacancy Control Board Number

VCB #: CON-12042023-0305