Research Data Coordinator - Pediatrics

$36,000 - $54,000/Yr

University of Texas M.D. Anderson - Houston, TX

Full-time - Entry Level

Houston, TX

Hospitals

About the position

The University of Texas MD Anderson Cancer Center is ranked the nation's top hospital for cancer care by U.S. News & World Report's 'Best Hospitals.' MD Anderson's mission is to eliminate cancer in Texas, the nation and the world through exceptional programs that integrate patient care, research and prevention. The ideal candidate will have a Bachelor's degree and be interested in a career in clinical research.

Responsibilities

• Assists the principal investigator in the collection and evaluation of research data.
• Abstracts and collects patient data from electronic health records and other relevant source documents.
• Demonstrates ability to gather information and determine the appropriate information to report.
• Enters research study data into paper or electronic case report forms (CRFs) or local data systems as required, per protocol requirements and departmental timelines.
• Performs ongoing and concurrent review of data to ensure completeness and accuracy.
• Addresses data entry omissions or inconsistencies and amends errors promptly.
• Provides data for study progress and patient safety reports, such as IRB continuing reviews and IND reports.
• Follows and adheres to department and sponsor guidelines to accomplish and complete daily work.
• Under the supervision of the Principal Investigator (PI) and research data supervisor/manager, assists the investigator in the overall conduction of assigned trials.
• Participates in Site Initiation Visits (SIVs), conference calls, and protocol meetings.
• Tracks and manages all relevant protocol paperwork and essential documents following sponsor requirements and institutional policies and procedures.
• Tracks protocol-required patient labs, tests, visits, and procedures through the electronic health record.
• Maintains knowledge of and assists in recording adverse events.
• Creates, maintains, and provides status reports to departmental contracts and budget team members to help facilitate appropriate study payment.
• Provides coverage for other data coordinators, informs appropriate staff, and arranges coverage for necessary functions when absent.
• Consults with the principal investigator and other department personnel verbally or in writing regarding ongoing studies.
• Demonstrates excellent oral and written communication skills when contacting other institutions and agencies (i.e., NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, computer-generated reports, and/or face-to-face.
• Prepares reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, quarterly, semiannually, and annually).
• Coordinates and participates in monitoring visits and internal or external audits to ensure objectives are met.
• Coordinates with research staff to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting, and protocol deviations or violations.
• Applies knowledge and experience when addressing study issues, gathering relevant information systematically, and making sound decisions.
• Assists with the recruitment of English and Spanish-speaking participants for the study, completing appropriate consent forms and documentation of study enrollment and study completion in MD Anderson's electronic research systems and medical records.
• Ensures that electronic study assessments are completed at the designated time points.
• In coordination with the lead study site study personnel, updates and maintains MD Anderson's site data in the study's database and generates weekly or monthly reports as needed to PIs.
• Creates and maintains organized research files for effective, ethical study execution and review/audit.
• Documents protocol deviations and violations in accordance with MD Anderson policy.
• Acts as a liaison with the research team, caregivers, and patients as well as other institutions and agencies and initiates, develops, and manages these relationships and networks.
• Provides psychosocial intervention, in English and Spanish, to caregivers of children with cancer, who are the study participants, as prescribed by the study plan, under the supervision of the site PI (a clinical psychologist).
• Reviews participant assessment items that might indicate a participant is experiencing emotional distress and coordinate appropriate psychosocial support with the PI (e.g., referrals to institutional and/or external psychosocial support services).
• Works in situations involving uncertainty, shifting priorities, and rapid change dealing constructively with mistakes and setbacks, and demonstrating flexibility.
• Maintains a level of professional expertise and credibility through attendance at both institutional and outside continuing education programs.

Requirements

• High school diploma or equivalent.
• Two years of related experience in the area of behavioral research study or direct patient care with children and caregivers/parents obtained from nursing, data gathering, or other related experience.
• Ability to read, write, comprehend, and speak fluent English and Spanish.

Nice-to-haves

• Bachelor's degree in health sciences, nursing, or related field.
• Licensed Psychological Associate, Licensed Professional Counselor, or Licensed Master Social Worker.
• Demonstrates experience in Good Clinical Practices (GCP) and the Code of Federal Regulations, at an exceeded and/or outstanding level.
• Software experience in Epic with the ability to cross-train others on its uses/capabilities.
• Experience with Microsoft Office applications, Electronic Data Capture (EDC) systems and RedCap.