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NYU Langone Health · 14 hours ago

Clinical Research Coordinator

Brooklyn, NY

Full-time

Onsite

Entry, Mid Level

$64K/yr - $66K/yr

1+ years exp

NYU Langone Health is a prominent healthcare institution, and they are seeking a Clinical Research Coordinator to join their Family Health Centers team. The role involves coordinating clinical research studies, ensuring compliance with protocols, and managing participant interactions throughout the research process.

EducationHealth CareHospitalMedicalNon Profit

Growth Opportunities

Responsibilities

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 Practice, HIPAA, and all required obligations to patient/subject, Principal Investigator, Research Team, sponsor, and other appropriate agencies

Participate in pre-screening and recruitment activities to identify patients that may be eligible for a clinical trial

Assist patients in understanding the schedule of assessments according to the approved protocol, coordination of appointments, and ancillary services

Write research notes in EPIC for specified visits as outlined by the protocol

Schedule participants according to the approved protocol; coordinate with ancillary service providers to ensure patients remain adherent to the protocol

Work with licensed clinicians to develop tracking forms for all active trials, maintain tracking forms throughout the lifecycle of the protocol

Compile enrollment packet materials to be reviewed and signed by investigator

Prepare for study visits: prepare clinical visit kits; lab and EKG orders, scheduling of biopsies and scans

AE and Conmed form completion in conjunction with licensed professional, and other tasks as needed

Act as primary point of contact for all biospecimen collection and at times participate in the collection, processing, and shipment of laboratory specimens, as per protocol

Under the supervision of the investigator, assist with the identification, review and reporting of adverse events/serious adverse events/reportable events, protocol deviations, and other unanticipated problems as appropriate

Participate in collection and documentation of Con Meds to be verified and signed by licensed clinicians before submission

Maintain follow up calendar ensuring all survival follow up assessments are completed per the protocol; performs assessments not requiring licensure

May perform EKGs and/or phlebotomy with documented training

Under the supervision of licensed clinicians administers ancillary assessments (i.e., Quality of Life questionnaires) and other assessments as approved by PI and study

Works with nurse and PI to review, compile, and submit weekly pharmacy lists to investigational pharmacy

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

Participate in coordination/preparation and submission of progress reports

Assist in reconciliation of any clinical discrepancies in data systems

Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities

Coordinate with materials/equipment management to ensure safety of study equipment and monitoring of current inspection stickers when applicable. Coordinates with Sponsor when applicable

Responsible for tracking site reimbursement and allocating patient stipends/compensation

Preparation and maintenance of study, subject and regulatory binders/files

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.)

Assist with budget development, assessment and submission

Participate in scientific publications

Function as a liaison between investigators, OSR, sponsoring agencies, regulatory agencies, other research sites (when applicable), other departments, etc

Qualification

Clinical PracticeClinical Research CoordinationMedical TerminologyMicrosoft OfficeProblem SolvingProfessional CertificationInterpersonal SkillsTime ManagementCommunication Skills

Required

Associate Degree Required, 2 years relevant experience OR Bachelor's Degree and 1 years experience in research or related healthcare setting

Computer literate with good interpersonal, oral, writing and verbal communication skills

Ability to identify, analyze and solve problems, ability to time manage and work well under pressure

Proficiency in using various Microsoft Office applications such as Word, Excel, Access, Power Point and Outlook. Familiar with Internet applications

Preferred

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

Professional certification (ACRP CCRC or SOCRA CCRP)

2-3 years experience in research or related experience preferred