Sr. Research Coordinator - Human Genetics and Genomics
NYU Langone Health
January 3, 2018
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Position Summary: We have an exciting opportunity to join our team as a Sr Research Coordinator.
The Senior Research Coordinator - Human Genetics & Genomics will work as part of a research laboratory team within the Center for Human Genetics & Genomics, investigating the molecular genetic basis of several complex diseases, including Hirschsprung disease, autism, hypertension and sudden cardiac death. The position will be responsible for all aspects of the Hirschsprung disease clinical research study, in which we are actively recruiting study subjects, as well as manage phenotype and genotype data from other genetics projects in the laboratory. In addition the position will oversee the protocol development for current and future assigned studies; assist with managing the recruitment process (develops advertising strategy, contacts media outlets and negotiate rates and monitor deadlines for submission of materials), enrollment, and study coordination; performs intra-operative monitoring and serves as liaison with internal and external funding agencies; ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and the sponsor(s); and interfaces directly with patients/subjects and the Principal Investigator in support of the clinical research studies. Works autonomously and with limited oversight.
Recruitment & Research Activities: Respond to in-person, e-mail and phone inquiries from research patients, research investigators and health care providers regarding Dr. Chakravartis laboratory genetic study of Hirschsprung disease that aims to identify the constituent genes and understand the molecular basis of multifactorial inheritance. The needs are to explain the research study, obtain informed consent and medical information in a confidential manner, and, coordinate collection of blood and tissue samples. Maintain and update database and files organizing this information. Update study website and publish periodic newsletter for families. Act as liaison to professional organizations and patient support groups. Provide genetic information (brochures, pamphlets, etc.) to families regarding Hirschsprung disease, answer questions regarding Hirschsprung disease clinical research study, and refer research study patients/families to other health care personnel as needed upon request. In addition, facilitate confirmation of incidental findings in genetic studies and refer participants to appropriate health care providers as needed.
Project Management: Coordinate a multi-site collaborative biorepository for Hirschsprung disease research. Serve on the Steering Committee for the biorepository and act as a liaison to other study sites. Facilitate completion of IRB applications, continuing review, and other compliance documents at actively enrolling collaborative sites. Plan quarterly conference calls for all collaborative sites and Steering Committee calls as needed. Manage shipment of study materials and receipt, processing, and database entry for all samples and data received for the biorepository. Obtain informed consent and coordinate collection of data and blood samples for NYULH and other referral center patients. Recruit new collaborative sites through management of the biorepository website and coordinating activities with appropriate professional societies.
Human Subjects Research As applicable, updates and submits necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials and any other appropriate parties in order to obtain approval to conduct human subjects research. Secures accurate signatures and forwards documents and/or forms to appropriate destination. Might prepare and submit monthly enrollment statistics to the Office of Clinical Trials and provide other information in timely manner, as necessary.
Clinical Competency may require competency in performing EKG, phlebotomy technique, centrifuge, handling, storing and shipping of specimens. Clinical training and didactic competency tests may be required to perform basic procedures as part of position expectations. In house training and certification will be provided. Other trainings and competencies may be included as required.
Study Regulations Maintains awareness of federal/state/local study regulatory status and keeps an up to date copy of regulatory documents. Assists with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Obtains and documents informed consent. Follows through regularly with the patient/subjects and reminds them of visits and compliance.
NYU Office of Clinical Trials/IRB Oversee all human subjects research regulatory processes for all ongoing and new projects in the laboratory, including writing IRB protocols, consent forms, Change in Research applications, and continuing reviews. Write progress reports for grants. Correspond with NYU Institutional Board (IRB), NYU Office of Clinical Trials and any other appropriate parties in order to obtain approval to conduct human subjects research and human subjects research activities. Ensure timely and accurate completion and submission of protocol and compliance requirements. Maintain record of all consent forms for all participants.
Reporting and Data Analysis - Perform analysis of genotypic and phenotypic data across the Hirschsprung disease genetic study. Prepares progress reports to funding agencies and presentations to sponsoring and regulatory agencies. Prepares and provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of studies as needed. Recommends changes/additions to established data fields. Analyses other data collected, formulates, prepares database and generates a complete measurement report for review by the director. May oversee staff assigned to this responsibility.
Continuous Learning: Position requires ongoing continuing education in all areas of research development (training programs are provided through the SOM). Promotes own professional growth and development in research role and maintains current expertise in area of practice. Maintains annual requirement of 10 CEUs in continuing research education; employee must demonstrate proof of ongoing research education. Serves as a resource to peers and works collaboratively with other disciplines within the area of expertise. There is a possibility to interact with nearly 30 genetic research teams across NYULH and external research sites through peer supervision and collaborative research
Decision Making and Problem Solving Combines and evaluates information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Resolves complex situations based on established policies and procedures and refers non solved issues and questions to the supervisor.
Financial/Protocol Development Develops draft budget, monitors budget throughout trial and recommends staffing levels based on reviewed protocol as needed. Reviews sponsor-proposed budget for adequate coverage and recommends changes as appropriate. Develops draft and final budgets together with study/project leader as needed. Preparation of funding reports to funding agencies as needed. Might identify new potential sponsors/agents for trials and researches and participate in the development of protocols as assigned.
Grants - Follow up and coordinates resolution of all issues progress reports to the sponsors to fund medical research in the division as needed. Oversees the preparation of grant applications and other grants related activities such as developing grants applications/proposals and fund raising activities if applicable. Collects and organizes required paperwork for submission if required for the grant.
Provides guidance, training and leadership to less experienced staff and trainees. May have input into staff evaluations.
Participates in special projects and performs other duties as required.
Demonstrates knowledge of the organizations Core Values and incorporates them into the performance of duties.
Minimum Qualifications: To qualify you must have a Bachelor 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 and 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: Masters degree in genetic counseling is preferred. Board certification in genetic counseling would be a plus.
Qualified candidates must be able to effectively communicate with all levels of the organization.
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