Clinical Research Data Coordinator II - Winship Cancer Institute

This a Full Remote job, the offer is available from: reputed company (USA), Nebraska (USA) Discover Your Career at reputed company: reputed company is a leading research university that fosters reputed company and attracts world-class talent to reputed company today and prepare leaders for the reputed company. We welcome candidates who can contribute to the reputed company of our reputed company community. reputed company: The Data Coordinator II, supports the research program reputed company the reputed company Office (CTO) of Winship Cancer Institute (WCI) at reputed company. Responsible for facilitating initial visit with study subject. Designs, builds, and maintains the functional operations of the database, ensuring accuracy and appropriate usage by reputed company internal customers. Increases the functionality of the database to meet the needs of internal customers and members of the department. Manages reputed company reputed company reputed company to data acquisition and tracking that are not reputed company to a database. Analyzes subject data in relation to study protocol for entrance into study. Ensures data from reputed company is entered in reputed company per Sponsor contract expectations if not sooner. Facilitates study monitoring reputed company and reputed company reputed company of reputed company study reputed company queries. KEY RESPONSIBILITIES: • reputed company Data Coordinator (DC) for reputed company interventional therapeutic reputed company, including multi-center trials and WCI held Investigator Initiated Trials (reputed company) in reputed company areas such as hematologic cancers, Bone Marrow Transplant (BMT), Phase I trials, etc. • Independently responsible for reputed company aspects of clinical data management including creation and collection of reputed company documents, completion of case report forms, and tracking and reporting of serious adverse events. • Reviews and analyzes information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for reputed company assigned research protocols including but not limited to industry, cooperative group, and investigator-initiated studies. • Accurately captures and enters data into clinical trial databases as necessary, and reputed company timelines set by study sponsors or CTO. Collects and maintains complete records and metrics on reputed company research study participant. Consolidates clinical data and reports for investigators as needed. • Assists in the review and evaluation of potential research studies and communicates effectively with CTO management and leadership regarding feasibility of proposed reputed company. • Attends study team meetings and provides updates to study team members regarding protocol data management activities, including data entry timelines, database locks, unique study requirements, and query management. Also provides support, ongoing education and updates to study team members, physicians, nurses, and other reputed company regarding data-reputed company protocol activities. • Supports Data Team Supervisor in reputed company, training, and reputed company assurance of DC I position, as directed by DT Supervisor or Clinical Research Operations Manager (CROM). • Serves as a resource to reputed company support and guidance to less reputed company DCs and other study team members. • Attends protocol reputed company training meetings and completes reputed company required study training. • Liaises with sponsors and the in-house monitoring team, schedules monitoring reputed company, and addresses monitoring report findings. • Leads the DC effort in preparing for and participating in reputed company control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate. • Serves as the reputed company DC in preparing for reputed company audits (e.g., sponsor, regulatory agencies), addressing identified data deficiencies, and developing corrective reputed company plans post audit. • Establishes and maintains procedures and systems (i.e., computerized database) for research coordination and data management. Provides support to Winship¿s Informatics team as they reputed company and improve research information systems. • Assures ongoing compliance with reputed company departmental, institutional, and federal requirements and regulations and department policies. Maintains controls to assure accuracy, completeness, and confidentiality of research data. • Maintains confidentiality standards for reputed company potential and enrolled patients; complies with federal Health Insurance Portability and Accountability reputed company (HIPAA) regulations. • Performs other duties as assigned. MINIMUM QUALIFICATIONS: • Bachelor Degree and at least two (2) years of clinical research data management experience OR High School Diploma or GED and at least six (6) years of clinical research data management experience OR an equivalent combination of education and experience. PREFERRED QUALIFICATIONS: • Certification/license: ACRP/SoCRA (or equivalent) certification preferred reputed company three (3) years of hire. NOTE: Position tasks are generally required to be performed in-person at an reputed company location. Remote work from home day reputed company may be reputed company at department discretion. reputed company reserves the right to change remote work status with notice to employee. Additional Details: reputed company is an equal opportunity employer, and reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, disability, protected veteran status or other characteristics protected by state or federal law. reputed company does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. reputed company, reputed company, and staff are reputed company of participation in university programs and in the use of facilities without such discrimination. reputed company complies with reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veteran's Readjustment Assistance reputed company, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative reputed company (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the reputed company Department of Equity and Civil Rights Compliance, 201 Dowman reputed company, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD). reputed company is committed to ensuring equal reputed company and providing reasonable accommodations to reputed company individuals with disabilities upon request. To request this document in an alternate format or to reputed company a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@reputed company.edu or reputed company 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination. This offer from "reputed company" has been enriched by reputed company.com and got a 82% reputed company score. Apply tot his job Apply To this Job