Clinical Research Data Manager 1

Department
 

BSD MED - Hematology and Oncology - Clinical Research Data Managers - Cluster 5

About the Department
 

The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.

Job Summary
 

The Clinical Research Data Manager 1 is responsible for meticulous and accurate clinical data management for each clinical trial. This includes: all patient data retrieval in its various forms (in-house/outside - prior histories, hospital floor admissions, ER visits, Clinic exams, MD office records, Scans, Pathology and Cytology, etc.), the preparation and maintenance of clinical research charts for each protocol patient, timely/daily retrieval, identification and entry of clinical research data into computer program databases, spreadsheets, chart flow-sheets, and case report forms.

Responsibilities

• Responsible for all data management aspects of clinical studies and efficiently performs all data management activities within an assigned study or studies.

• Provides data management expertise to the team in identifying opportunities for improvement.

• Ensures validity of research results through timely, accurate, and complete data submission, query resolution, and reporting of deviations.

• Demonstrates proficiency in the use of clinical and research-related computer programs.

• Attends multidisciplinary conferences and workshops.

• Schedules, prepares and participates in all pharmaceutical site visits.

• Assists Research Nurse(s) and appropriate departmental, and laboratory staff in collection, storage, and shipment of patient specimens, radiology scans, reports, etc.

• Ensures that relevant data from the source document are abstracted and recorded in the clinical trial case report forms and that every data point can be verified within the source document.

• Utilizes analytical thinking, attention to detail, and problem-solving skills.

• Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• Performs other related work as needed.

Minimum Qualifications
 

Education:

Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).

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Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

• Bachelor's degree.

Technical Skills or Knowledge:

• Demonstrated ability to abstract subject data from medical record/source documentation and enter into care report forms and/or databases.

• Experience generating and resolving queries and/or monitoring data.

• Proficient in Microsoft Word, Excel and Adobe Acrobat.

• Knowledge of medical and/or/clinical trial terminology.

• Knowledge in relevant scientific field.

Preferred Competencies

• Handle competing demands with diplomacy and enthusiasm.

• Perform research data management with minimal supervision.

• Strong data management skills and attention to detail.

• Work collaboratively and with divisional research offices.

• Maintain a high degree of confidentiality with clinical data and client's proprietary data.

• Adaptability to changing working situations and work assignments.

• Ability to work independently and as part of a team.

• Analytical skills.

• Strong attention to detail.

• Excellent multi-tasking skills.

Application Documents

• Resume/CV (required)

• Cover Letter (required)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family
 

Research

Role Impact
 

Individual Contributor

FLSA Status
 

Non-Exempt

Pay Frequency
 

Biweekly