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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