Research Data Manager

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The University of Miami is currently seeking a Research Data Manager (Medical) to work at UTower in Miami.

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

The 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. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

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About Us

The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation.

The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride.

The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings.

Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019.

The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022.

Transforming Lives

With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.