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Position Summary:
We have an exciting opportunity to join our team as a Senior Research Coordinator.
The Senior Research Coordinator will work collaboratively with the Principal Investigator (PI), and the study team on medication-oriented/behavioral clinical research trials and other research studies at 1 Park Ave, and Center for Brain Health, Bellevue Hospital Center.
The Senior Research Coordinator will take part in managing day-to-day study operations and participant activities across two research studies.
S/he will serve as lead coordinator for regulatory, reporting, and recruitment responsibilities across all studies. S/he will be responsible for tracking study goals, managing participant recruitment, and coordinating all study activities in conjunction with the study team and the PI.
The candidate will be expected to work with a high level of independence.
The Senior Research Coordinator will be responsible for providing weekly progress reports to the PI and research team, tracking subjects, managing study data, managing data entry, and collecting and maintaining data as needed. The incumbent will further assist the Sr. Research Project Manager in developing presentations, drafting IRB documents, and providing annual reports to the funder.
Job Responsibilities:
Sr. Research Project Coordination and Management: Develop study-specific project plansand SOPs, from study initiation through recruitment close out and finalreporting; manage timelines, resources and project milestones in conjunctionwith PI, project team and sponsor. Provide day-to-day project management for researchas assigned including protocol compliance, staff supervision, participant management, data quality, problem resolution and leadership and coordination ofthe study team. Manage Research Navigator, CRMS, REDCap, TrialMaster, and otherNYU systems as well as Epic electronic system.
Reporting and Communication Management: Communicate with PI regarding studyoperations and achievement of study goals. Provide PI and other team members asappropriate information regarding protocol deviations, safety events, and dataqueries. Lead preparation of study reports, including progress reports to funding agencies and reports to the Data Safety Monitoring Committee whenrequired. Gather and prepare information as requested for IRB submissions.Participate in national and local conference calls and meetings withcollaborators. Collaborate with PI and team members on the dissemination of researchfindings, including publications and presentations, as appropriate.
Protocol Compliance Lead: Develop and manage all IRB and FDA submissions/reports. Ensure thatstudy activities are carried out in accordance with the protocol, HIPAA andGCP, including but not limited to participant recruitment & screening,study intervention, medication documentation and management, participant research visits, follow-up, and required documentation. Demonstrate thoroughknowledge of study rationale, inclusion/exclusion criteria, and proceduresassociated with the study.
Staff onboarding and supervision: Assist with staff onboarding and supervision as assignedby the PI, including developing staff trainings for research projects.
Participant flow management: Develop study-specific participant recruitment andretention plans in conjunction with PI; monitor goals and trouble-shootrecruitment/retention challenges. Recruit and screen patients for eligibility,completing necessary questionnaires, assessments and paperwork as needed.Maintain patient confidentiality. Track participant flow through the study andupdate tracking logs in an accurate and timely manner. Contact participants toschedule them for study visits and send retention letters as needed. Manage theparticipant payment system for the project(s), including maintenance of the reimbursementpayment system, documentation of participant compensation, and weekly reviewwith PI.
Participant visits: Conduct participant visits as per visit specific SOP as needed. Contact participants to schedule them for study visits and send retention letters as needed. Manage the participant payment system for the project(s), including maintenance of the reimbursement payment system, documentation of participantcompensation, and weekly review with PI.
Data Management & Integrity: Review entered data, resolve data queries, andobtain missing information. Document all data accurately and according toprotocol. Manage Study Binder and TrialMaster databases including assistingwith programming data collection instructions, user management, generatingreports, and implementing edits to forms. Track and document shipments andstorage of biological specimens.
QualityAssurance: Conduct regular checks of ICF, source documents, study data and otherstudy documentation to ensure that the project is in compliance and thatnecessary corrections to documents or processes occur in a timely manner.Coordinate with internal and external monitors/auditors.
Team Leadership: Establish and maintain positive relationshipswith study team members, NYU medical center cores and units, internal andexternal stakeholders, sponsors, and ancillary staff. Coordinate studyactivities through open communication with Research Assistants, PI, clinicalstaff and external site staff.
ProblemResolution: Identify, respond to, and participate in the resolution ofpotential and actual problems in study operations and participant activities.
Participate in special projects and performs otherduties as assigned.
Minimum Qualifications:
To qualify you must have a Bachelor's degree or equivalent in business administration, health care administration or related discipline. Minimum of four years of progressively responsible related experience coordinating clinical/research trials studies. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective oral, written, communication, interpersonal skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Ability to work and make decisions independently. Time management skills and ability to multi task. Strong understanding and knowledge base of coordination requirements associated with clinical/research trials. Ability to identify, analyze and solve problems; ability to work well under pressure.
Preferred Qualifications:
Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines).
Knowledge of basic medical terminology is preferred.
Interest in and experience with addictions and/or clinical research, especially translational research, is a plus.
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.
NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. 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 $63,547.00 - $74,152.00 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.
To view the Pay Transparency Notice, please click here
