RESEARCH DATA COORDINATOR I - GI

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Summary The RDC I is responsible for the data management of multiple research projects. The position is required to review and synthesize information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract industry, cooperative, and investigator-initiated trial data as specified by assigned research protocols. The role works with the study coordinator and monitors regarding all data requirements to ensure data is captured according to the study protocol. The RDC I is expected to work under moderate supervision and direction from the manager/supervisor and Principal Investigator (PI) to ensure accurate data is entered and reported into study database systems. The RDC I consults frequently with the study coordinator and trial sponsor and internal monitors regarding data requirements, query resolution, and data capture. This position has the opportunity for career growth within the Research Data Coordinator career path. Research Data Coordinator I (RDC I)

Position Highlights:

The Research Data Coordinator Level I (RDC I) is responsible for the data management of multiple research projects. The position is required to review and synthesize information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract industry, cooperative, and investigator-initiated trial data as specified by assigned research protocols. The role works with the study coordinator and monitors regarding all data requirements to ensure data is captured according to the study protocol. The RDC I is expected to work under moderate supervision and direction from the manager/supervisor and Principal Investigator (PI) to ensure accurate data is entered and reported into study database systems. The RDC I consults frequently with the study coordinator and trial sponsor and internal monitors regarding data requirements, query resolution, and data capture. This position has the opportunity for career growth within the Research Data Coordinator career path. Education & Experience Required:

High School Diploma/GED with 1 year experience using automated data processing techniques, word process software or data base software programs. *In lieu of experience, an AA/AS degree is acceptable. Detailed Job Responsibilities: Technical Data Coordinator Functions: 1. Complies with Institutional policies, standard operating procedures (SOPs) and guidelines. 2. Adheres to Good Clinical Practices and the data requirements of the clinical trial protocol. 3. Abstracts information from data collection tools or subject's medical record and enters required protocol data into the study designated data control system. 4. Ensures data is entered/reported in a timely manner keeping with clinical trial agreements and institutional standard operating procedures. 5. Applies an understanding of medical terminology, most specifically terms related to anatomy, physiology, oncology, pathology, radiology and cancer treatment modalities. 6. Reads and understands components or a subject's medical history, including but not limited to radiology and pathology reports, operative reports, history and physical reports, physician and nurses' notes, discharge summaries, treatment protocol descriptions and physicians' letters. 7. Moderate supervision with some latitude for independent judgment. Receives assistance in the completion of more complex or new assignments from Manager/Supervisor or those more senior. 8. Meets 1:1 with the staff weekly or as needed

Data Quality Functions: 1. Creation of basic data manuals for studies assigned. Ensures data is entered according to case report guidelines and accurate manner. 2. Recognizes and identifies data discrepancies and/or missing data and follows up with investigators and the study team to resolve. 3. Proofs case report forms (CRFs) for data entry errors; reviews CRFs for data logic and to identify possible missing data; asks for assistance if data presents a problem or is difficult to understand in context of case. 4. Resolve and track queries or outstanding data to address problematic data identified during data review activities and apply proper modification / correction to the data. 5. Maintain awareness of details of clinical data to identify missing or inaccurate data; and track data inconsistencies for study team review. 6. Maintains electronic and paper files necessary for data abstraction and follow-up functions in an organized fashion. 7. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

Research Activities: 1. Collaborate with study coordinator to document and report study patient enrollment, treatment, and follow-up into study database, including protocol adherence, adverse events, and treatment outcomes. 2. Prepare documents for internal and/or external compliance monitor review/audit. 3. Assists with the coordination of organized meetings, conference calls and training. 4. Participates in interim monitoring visits, internal audits and external audits/inspections. 5. Reviews monitoring/audit reports and resolves errors to ensure integrity of data. 6. Drafts response to monitoring letters for management/PI review. 7. Performs related responsibilities as required.

Department Functions: 1. Provides coverage for teammates as appropriate. 2. Establishes a congenial rapport with various stakeholders including internal/external monitors and auditors. 3. Receives and returns phone calls from internal and external customers. Triage calls appropriately. 4. Displays a professional appearance and impression, adhering to dress codes guidelines. 5. Informs appropriate areas and personnel of concerns, changes, or delays regarding the study data. 7. Aids team members as assigned by manager/supervisor. 8. Practices and promotes teamwork within the program as well the department.

Educational/Professional Activities: 1. Attend and participate in at least 25% staff meeting per year or obtain information presented (if absent) by reviewing the minutes. 2. Minimum of 10 relevant continuing educational contact hours earned during the calendar year (in accordance with department training requirement SOP). 3. Complete annual self-evaluation and request peers evaluations, complete peer evaluations as assigned annually. 4. Attend and actively participate in regularly scheduled multidisciplinary tumor boards, staff meetings, disease site program research meetings and role specific meetings. 5. Completes annual competencies and passes related assessments as assigned by leadership. 6. Works to build stable working relationships and develops competence by performing structured work assignments. Salary Range Salary ranges posted for this position represent the expected base pay range for the role. Actual compensation may vary based on location and a variety of job-related factors, including experience, skills, education, and internal equity among Team Members in similar positions.

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