Clinical Research Coordinator (29674)

Physician Affiliate Group of New York•Bronx, NY

About The Position

Physician Affiliate Group of New York (PAGNY) is adding a Clinical Research Coordinator to the group at NYC Health + Hospitals/Lincoln. Lincoln Medical Center is a designated Level I Trauma and Stroke Center and has Centers of Excellence in all medical specialties, including its award-winning Cancer and Breast Centers. Today, Lincoln stands as a leader in the transformation in healthcare in the Downtown Bronx community. The hospital maintains a strong academic affiliation with Weill Medical College of Cornell University to maintain its high healthcare delivery standards. The mission of NYC Health + Hospitals is to extend equally to all New Yorkers, regardless of the ability to pay, comprehensive health services of the highest quality in an atmosphere of humane care, dignity, and respect. Their Values are built on a foundation of social and racial equity and has established the ICARE standards for all staff. NYC Health + Hospitals is the nation’s largest municipal health care delivery system in the United States. Dedicated to providing the highest quality health care services to all New Yorkers with compassion, dignity and respect, and regardless of immigration status or ability to pay. The Clinical Research Coordinator (CRC) plays a vital role in executing clinical trials while ensuring the highest standard of patient care. The CRC works closely with Principal Investigators (PIs), sponsors, and institutional review boards (IRBs) to manage day-to-day trial operations, ensure strict protocol adherence, manage study documentation, and safeguard participant well-being throughout the research process. Opportunity Details: Perform ECGs and Phlebotomy related study tasks and execute other protocol-specific procedures. Monitor patients closely for Adverse Events (AEs) and Serious Adverse Events (SAEs), providing timely medical interventions and reporting as required. Direct the screening, enrollment, and retention of study participants. Conduct the Informed Consent process, ensuring patients fully understand the study's risks, benefits, and requirements before participation. Schedule and coordinate all patient visits, laboratory tests, imaging, and specialist consultations required by the protocol. Collaborate with the PI to ensure the trial is executed in strict adherence to Good Clinical Practice (GCP) guidelines and federal regulations (FDA). Assist in creating or updating department Standard Operating Procedures (SOPs) related to clinical research nursing. Collaborate effectively with interdisciplinary teams, including research pharmacists, regulatory coordinators, and laboratory staff.

Requirements

Bachelor’s Degree in Science, strongly preferred.
Minimum of Two (2) years’ research coordintor strongly preferred.
Current Good Clinical Practice (GCP) and Human Subject Protection (HSP) training.
Excellent phlebotomy skills.
Strong understanding of clinical trial phases, FDA regulations, and ICH-GCP guidelines.
Exceptional attention to detail and strong organizational skills.
Proficiency with Electronic Medical Records (EMR) and Electronic Data Capture (EDC) systems.

Nice To Haves

Certification as a Clinical Research Professional (CCRP via SOCRA) or Clinical Research Coordinator (CCRC via ACRP) is a strong plus.

Responsibilities

Perform ECGs and Phlebotomy related study tasks and execute other protocol-specific procedures.
Monitor patients closely for Adverse Events (AEs) and Serious Adverse Events (SAEs), providing timely medical interventions and reporting as required.
Direct the screening, enrollment, and retention of study participants.
Conduct the Informed Consent process, ensuring patients fully understand the study's risks, benefits, and requirements before participation.
Schedule and coordinate all patient visits, laboratory tests, imaging, and specialist consultations required by the protocol.
Collaborate with the PI to ensure the trial is executed in strict adherence to Good Clinical Practice (GCP) guidelines and federal regulations (FDA).
Assist in creating or updating department Standard Operating Procedures (SOPs) related to clinical research nursing.
Collaborate effectively with interdisciplinary teams, including research pharmacists, regulatory coordinators, and laboratory staff.

Benefits

401(k) Company Contribution (subject to IRS contribution limits): Employees are immediately vested in a 3% company contribution of base earnings. No employee match is required. After one year of service, employees receive an additional 7% company contribution of base earnings. No employee match is required.
Generous Annual Paid Time Off (PTO): Vacation and Holiday.
Medical, Prescription, and Dental Coverage: Top tier plans with employee contributions significantly below market rates.
Life Insurance and Accidental Death and Dismemberment (AD&D) Coverage: Equal to 3x your salary (up to a maximum of $250,000) provided at no cost to you. Additional employee-paid Voluntary Life and AD&D coverage is available for you and your family.
Healthcare and Dependent Care Flexible Spending Accounts (FSAs).
Pre-tax employee-paid contributions for commuting expenses.

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