Senior Clinical Research Coordinator

NYU Langone Health • New York, NY

3h • $70,482 - $88,237 • Onsite

About The Position

NYU Grossman School of Medicine is a top-ranked medical school with a long history of shaping medical history. As an integral part of NYU Langone Health, the school is dedicated to improving the human condition through education, research, and patient care. NYU Langone Health values equity and inclusion, striving to be a place where diverse talent can thrive. This role is an exciting opportunity to join the team as a Senior Clinical Research Coordinator (Sr. CRC). The Sr. CRC actively participates in all aspects of clinical research studies, from planning and feasibility to completion. This includes regulatory maintenance, case management of participants, lab processing, and data collection. Working independently under general supervision within the CTSI Clinical Research Centers, the Sr. CRC collaborates with the Principal Investigator and study team to ensure Good Clinical Practices (GCP) compliance and adherence to study protocols. The Sr. CRC also provides mentorship to junior coordinators and participates in the Clinical Research Centers Orientation Program.

Requirements

• Education: Bachelor's Degree or equivalent combination of education and experience required.
• Professional certification (ACRP CCRC or SOCRA CCRP) required.
• Computer literate with good interpersonal, writing and verbal communication skills.
• 4 years relevant clinical experience required with a minimum of one year as a CRC in the CCU.
• Effective oral, written, communication, interpersonal skills.
• Must be able to work under the direction of supervision.
• Ability to identify, analyze and solve problems.
• Time management skills and ability to work well under pressure.
• Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook.
• Familiar with Internet applications.
• Intermediate competency in medical terminology, and Good Clinical Practice (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.
• Proficient analytical, interpersonal, writing and verbal communication skills.
• The ability to manage priorities and deadlines and maintain service level expectations for tasks.
• Adaptability, independently completes tasks and works within deadlines and collaborate effectively as part of a team.
• Commitment to team problem-solving approach using a research and patient-focused model.
• Ability to identify, analyze and solve problems.
• Ability to multi-task and prioritize in a fast-paced work environment, time management skills and an ability to work well under pressure.
• Organizational skills both to function independently and as a member of a professional team.
• Ability to work with diverse groups of people.
• Effective oral, written, communication, interpersonal skills.
• Must be able to work under the direction of supervision.

Nice To Haves

• Intermediate competency in medical terminology, and 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).
• 3-5 years experience in research or related experience preferred.

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 Practices, HIPAA, and all required obligations to patient/subject, Principal Investigator, Research Team and sponsor and other appropriate agencies.
• Work with licensed clinicians and research managers to develop tracking forms for all active trials, maintain tracking forms throughout the life cycle of the protocol.
• Act as primary point of contact for all assigned studies and patient visits. Coordinate with junior coordinators their schedules for the week.
• Help to reconcile any clinical discrepancies in data with junior coordinators.
• Participates in pre-screening and recruitment activities to identify patients that may be eligible for a clinical trial. Trains clinical research coordinators on the process of pre-screening.
• 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.
• Helps compile enrollment packet materials to be reviewed and signed by investigators.
• 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.
• Act as primary point of contact for all bio-specimen collections and participate in the collection, processing, and shipment of laboratory specimens, as per protocol.
• Under the supervision of investigators, assist with the identification, review and reporting of adverse events/serious adverse events/reportable events, protocol deviations, and other unanticipated problems as appropriate.
• Maintain follow up calendar ensuring all 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 research manager and PI to review, compile, and submit weekly pharmacy lists to investigational pharmacy.
• Oversee the submission of necessary documents required by the NYU Institutional Review Board (IRB), and any other appropriate parties to obtain approval to conduct human subjects research.
• Participates in the feasibility and complexity assessment process for new protocols.
• Create and place research notes in EPIC.
• 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.
• Additional responsibilities as needed including Help in the development of SOPs, policy changes, education sessions, and quality improvement projects.
• 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.)
• Assists with training and orientation of new Associate CRCs and CRCs. Provides ongoing mentorship to Associate CRCs and CRCs.
• 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.

Benefits

• Financial security benefits
• Generous time-off program
• Employee resources groups for peer support
• Holistic employee wellness program (physical, mental, nutritional, sleep, social, financial, and preventive care)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior