Position Summary:
Responsible for providing moderate to advanced range of coordination of Research studies conducted at the Medical Center, assists with the recruitment, enrollment, grant submissions, research data collection and study coordination activities. 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 sponsor. Interfaces directly with patients/subjects and Principal Investigator in support of the clinical trials if applicable. Establishes liaisons with relevant parties at the Medical Center that may include: Research Nurses, Research Pharmacists, Program Managers, Medical Technicians, Clinical Information Systems and regulatory Services. Might assist in the initiation and management of research studies. Works under general direction
Job Responsibilities:
• Grants -Prepares and submit grant applications and other grants related an activity such as developing grants applications/proposals and fund raising activities if applicable. Collects and organizes required paperwork for submission if applicable. Follow up and coordinates resolution of all issues progress. Reports to the sponsors to fund medical research in the division.
• Human Subjects' Research - As applicable, oversee the submission of 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 (e.g., ensures the update and submission of necessary documents and/or forms to appropriate destination). Might prepare, audit and submit monthly enrollment statistics to the Office of Clinical Trials, and provides other information in timely manner, as necessary.
• Study Regulations - Aware of study regulatory status and keep 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. Follows through regularly with the patient/subjects reminding them of visits and compliance. May monitor any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse.
• Data Management - Responsible for collecting and auditing patient information for the research project(s). This may include abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc); abstraction of data for publications, or data collection from outside physicians offices. Audits and manages data from and into the database. Prepares forms and reports, compiles and analyses data, statistics, and other materials for reports. Conducts study visits, obtains and documents information within the time frame specified.
• Budget - Develops a preliminary draft budget and submit to the Director/Principal Investigator. Reviews sponsor-proposed budget for adequate coverage and recommend changes as appropriate. Assists in the preparation of funding reports to funding agencies and helps identify new potential sponsors/agents for trials and researches. Monitor budget throughout trial.
• Decision Making and Problems 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 and refers non solved issues and questions with recommendation to supervisor.
• Participates in special projects and performs other duties as required.
• Recruitment - Screens potential patients/subjects for eligibility to the study. This may include gathering information from the medical record, physician referral, advertisement and directly scheduling a visit to evaluate the patient/subject. Reviews all the elements of the screening process with the Principal Investigator that being: inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study.
• Clinical Competency - 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.
Job Description
• 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.
• Reporting and Analysis- Researches, compiles and consolidates data and conducts preliminary analyzes to data collected for presentation to sponsoring and regulatory agencies. Provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Formulates, prepares database and generates preliminary measurement reports for review by PI. May complete assessments on study subjects/patients following protocol (with proper training); continues to follow-through with items and patients as part of the research study.
Additional Position Responsibilities:
Bachelor's Degree Required
Minimum Experience: 2
Communication Strength Required
English Required
Minimum Qualifications:
Bachelor degree or equivalent in business administration, health care administration or related field. Minimum of two years of progressively responsible project coordination experience, preferably in a research setting. Proficiency in using various Microsoft Office applications such as Word, 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. Commitment to continuous learning as required by department administration. Ability to operate research related equipment Ability to work and make decisions independently. Time management skills and ability to multitask. 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. Experience working in an Academic Medical Center preferred
Working Conditions:
Might require physical and manual dexterity needed to lift and support patients and to calibrate equipment.
