Research Data Manager

University of Miami; Miami (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salaries

Job summary

The University of Miami Health System is seeking a Research Data Manager (Medical) to support the Adult Transplantation and Cellular Therapy Program (TCTP) in collecting, abstracting, and submitting patient data to NMDP and CIBMTR. The role emphasizes data integrity, compliance, and timely reporting.

You will coordinate with data coordinators, nurses, and providers, conduct audits, and train staff, ensuring accuracy for regulatory submissions and audits by bodies like NMDP, CIBMTR, and FACT.

Qualifications

• AS or Bachelor Degree, preferably in nursing or healthcare or science related field.
• CITI Certification within 30 days of hire required.
• A minimum of three years of effective work-related experience in hematology/oncology, research compliance or study coordination and auditing.
• High-level interpersonal skills are required.
• Professional certification/licensure in nursing, clinical research, research compliance, auditing, GCP-related field preferred.

Responsibilities

• Gather, abstract and submit patient data per NMDP and CIBMTR.
• Monitor timeliness and accuracy of data submission as per CPI.
• Coordinate with CIBMTR, NMDP and data coordinators/peers from other institutions.
• Meet with TCTP providers to review collected data.
• Develop processes for obtaining external data from referring physicians’ offices.
• Ensure data gathered prior to transplant submissions to CIBMTR.
• Conduct routine audits to ensure compliance and data integrity.
• Assist with audits and regulatory agency submissions and responses.
• Train other Research Data Managers.
• Maintain Data Management policies and SOPs.

Skills

Microsoft Excel

Microsoft Word

Microsoft Access

PowerPoint

Data analysis

Communication skills

Attention to detail

Problem solving

Education

AS or Bachelor Degree in nursing/healthcare/science

Job description

SUMMARY

The primary function of the Research Data Manager (Medical) is to meet the Adult Transplantation and Cellular Therapy Program's (TCTP) need to provide data to the National Marrow Donor Program (NMDP) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The Research Data Manager organizes, researches, abstracts, and captures data pertaining to all pre, intra and post stem cell transplant patients as required by law and agreements for submission to federal entities. The Research Data Manager coordinates, maintains, captures and enters data into the various databases created for the TCTP. Conducts routing data audits of submitted data collection forms; participates in special data validation projects, investigates problems with forms data entry, and supports other research and quality activities for the Adult Translantatoin and Cellular Therapy Program. This position requires a significant degree of independence, organizational skills and ability to analyze data to create and submit forms as required by the NMDP and CIBMTR. The Research Data Manager must demonstrate close attention to detail and have the ability to provide solutions to complex issues.

Primary Duties and Responsibilities:

• Gather, abstract and submit patient data in compliance with the NMDP and CIBMTR
• Monitors timeliness for data submission ensuring accurate and timely submission of data meeting departmental and CIBMTR Continuous Process Improvement (CPI)
• Establishes and maintains effective communication and working relationships with CIBMTR, NMDP and data coordinators/peers from other institutions.
• Meets with TCTP providers as needed to review collected data
• Develops processes for obtaining external data from referring physician's offices for data capture
• Work in conjunction with other key members of the TCTP team to ensure required data is gathered prior to each transplant submission to CIBMTR
• Conducts routine, focused and directed audits of CIBMTR required data to ensure compliance.
• Advises appropriate institutional officials of deficiencies and recommends necessary corrective actions, with follow up to ensure that needed actions have been implemented.
• Performs validation audits of CIBMTR and TCTP database.
• Prepares audit reports of findings/inquiries for internal and/or external use.
• Assists in or conducts the preparation for CIBMTR, NMDP, FACT or other regulatory agency audits.
• Assists with required written responses to observations resulting from audits conducted by regulatory agencies.
• Training of other Research Data Managers.
• Awareness of new legislation or changes in regulations that might affect the TCTP compliance in conducting research, recommending changes to administrative policies and procedures, as appropriate.
• Assists in the creation and maintenance of Data Management policies and SOPs in maintaining compliance with research standards and guidelines.
• Maintains data integrity of TCTP related databases and electronic and paper audit files.
• Performs other related duties as required by the TCTP.
• Excellent oral and written communication skills are essential. Strong critical thinking, problem solving and attentiveness to detail required.
• Ability to use judgment to prioritize activities and work towards completion within the required time frame
• Knowledge of Microsoft Office applications (Excel, Word, Access, PowerPoint) skills

Education Requirements (Essential Requirements):

• AS or Bachelor Degree, preferably in nursing or healthcare or science related field
• Successful completion of CITI Certification within 30 days of hire required
• A minimum of three years of effective work-related experience, including nursing, hematology oncology, research compliance or study coordination and auditing experience.
• High-level interpersonal skills are required.
• Excellent English oral and written communication skills and strong computer skills are required.
• Professional certification/licensure recommended in at least one of the following areas: nursing, clinical research, research compliance, auditing, GCP-related field, etc. is preferred

Work Experience Requirements (Essential Requirements):

• Three years of relevant work experience in hematology/oncology

Benefits:

• University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine.