Contract Senior Clinical Research Associate Jobs in Basking Ridge, NJ

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. 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 Senior Clinical Research Coordinator.
The Senior Clinical Research Coordinator (Sr. CRC) is an active participant in all related clinical research studies from research planning and feasibility to completion of all study activities, including direct involvement in pre- and post-activation regulatory maintenance, case management of study participants, lab collection and processing, and data collection. The Sr. CRC works independently under the general supervision of research management within the CTSI Clinical Research Centers, in collaboration with the Principal Investigator and other study team members, to ensure GCP compliance in the conduct of the study, and adherence to the study protocol. The Sr. CRC provides mentorship to Associate Clinical Research Coordinators and Clinical Research Coordinators and participates in the Clinical Research Centers Orientation Program.
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.

1. 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.

1. Act as primary point of contact for all assigned studies and patient visits. Coordinate with junior coordinators their schedules for the week.

1. Help to reconcile any clinical discrepancies in data with junior coordinators

1. 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.

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

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

1. Helps compile enrollment packet materials to be reviewed and signed by investigators.

1. 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.

1. 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.

1. 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.

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

1. May perform EKGs and/or phlebotomy with documented training.

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

1. Works with research manager 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 Review Board (IRB), and any other appropriate parties to obtain approval to conduct human subjects research.

1. Participates in the feasibility and complexity assessment process for new protocols.

1. Create and place research notes in EPIC

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

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

1. Responsible for tracking site reimbursement and allocating patient stipends/compensation.

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

1. Additional responsibilities as needed including Help in the development of SOPs, policy changes, education sessions, and quality improvement projects.

Additional Position Specific Responsibilities:
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.
Minimum Qualifications:
To qualify you must have a 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. Experience: 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. Knowledge, Skills and Abilities: 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.
Preferred Qualifications:
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.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Grossman School of Medicine 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 Grossman School of Medicine 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 $70,481.61 - $88,236.75 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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