[NYUSOM]
        [NYULMC_P]










POSITION DESCRIPTION

DEPARTMENT:       Breast Surgery- Surgical Oncology

JOB TITLE:              Research Data Manager


GENERAL SUMMARY:  Provides data management support for clinical research protocols related to the Breast Cancer Database and High Risk Breast Cancer Consortium.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
Incumbent may carry out some or all of the following duties:

       i        DATABASE METHODOLOGY:

Utilizes the necessary tools to ensure protocol compliance to conduct direct data research.


Ø  Utilizes established methodologies to collect patient information for the research project(s).

Ø  Extracts data for publications, or provides data collection from outside physicians' offices.

Ø  Formats and uses tools to facilitate data collection (e.g., calendars, schedules, tracking logs, etc).
Ø  Ensures protocol compliance, that is, that standard steps regarding eligibility criteria, follow-up, and required documentation is consistently followed in the time frame specified.

Ø  Compiles data and assists in consolidating and analyzing data for sponsoring and regulatory agencies.
Ø  Is responsible to ensure that data collection is correct and consistent with the source document and completed in a timely and organized manner.
Ø  Completes paperwork and forms in a neat, accurate, timely manner.
Ø  Maintains files of all required on-going documentation and forms.
Ø  Assists in preparation for bio-statistical analyses and required reporting.
Ø  Ensures that information in computer database is accurate, entered and maintained on a timely basis.

    ii        CLINICAL RESEARCH DUTIES
Ø  Thorough knowledge of research study, study rationale, study subject, and clinical procedures associated with the study.
Ø  Review all the elements of the screening process with the Research Director (RD).
Ø  Collaborate with various personnel that may be involved in assisting with specific aspects in the study.
Ø  Have thorough knowledge of policies and procedures of the host institution where the study is being conducted and the regulatory requirements such as IRB and other approvals if necessary.
Ø  Works with the principal investigators and research staff on monitoring the overall conduct of the study.
Ø  Works with the research staff in reporting adverse events to the appropriate regulatory bodies as instructed.
Ø  Tracks clinical milestones and patient accruals to help evaluate the progress of studies.

iii        INTERACTS WITH MEDICAL STAFF, and SITE MONITORS:
Coordinates, Facilitates and Communicates with Staff and Non-Staff to Produce Required Results.


Ø  Works with RD and research staff as part of a team.
Ø  Demonstrates knowledge of and follows proper clinical study processes within current policies and procedures.
Ø  Recognizes identifies, and moves issues forward as appropriate.
Ø  Utilizes available resources and established procedures in order to rectify problems, communicates all changes.
Ø  Liaisons with monitors during site visits, providing them with assistance specific to the monitoring visit.


iv        COORDINATION OF MATERIALS AND VARIED STUDY ITEMS:


Ø  Coordinates the shipment and transfer of varied types of materials among the various departments and labs.
Ø  Works with departments, labs, other personnel and areas as needed, to ensure the timely transfer of items and biological materials: study drugs; histology slides; serum, urine, blood samples, etc., using appropriate precautions at all times.
Ø  Attends appropriate trainings in the proper handling and collection of biological substances and the packaging and shipment of samples as well as required IRB and HIPAA tutorial.

V     ADMINISTRATION, ANALYSIS, REPORTING, and Filing:

Ø  Coordinate IRB approved subject study reimbursements according to standard operating procedures.
Ø  Maintain complete, accurate subject charts, case report forms, enrollment logs, and hospital records
Ø  Maintain files in an organized and up-to-date manner in order to facilitate their retrieval and maintains copies of all required on-going documentation and forms for the files.

MINIMAL HIRING QUALIFICATIONS:

¨       Master's Degree plus three years related experience or equivalent combination of education and experience.
¨       Statistical skills, including SAS and SPSS
¨       Computer skills, preferably experienced with oracle-based data systems (eVelos), EPIC, etc.
¨       Proven communication skills, ability to work independently within a multidisciplinary environment.



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