The Senior Coordinator of Research Data collaborates with the research team and principal investigator in managing research protocols, assuring protocol compliance, collecting protocol-specific information utilizing a paper and/or computer database system and communicating with patients and staff regarding protocol information (survival follow-ups, scheduling of appointments, and obtaining records from outside institutions).Key FunctionsClinical Trial Management:
Reads protocol and develop systems for screening and scheduling patients with the assistance of the departmental database Prometheus.
Responsible for accurate and timely transcription of study data to paper and/or electronic Case Report Form (CRF), retrieving information from electronic record, chart, and/or phone call. May require face-to-face interaction with patients. Requires ability to gather relevant information and determine the appropriate information to report.
Maintains knowledge of industry protocol databases and electronic applications as assigned. Must be proficient in the use of Microsoft office applications, departmental electronic data systems, and institutional research databases.
Consults with principal investigator (PI) regarding ongoing clinical trial assignments. Works closely with clinical studies coordinator and research nurse to ensure consistency between protocol database and source documentation; includes generating written queries for missing/deficient source documentation and assisting clinical studies coordinator and research nurse as needed with obtaining patient charts and outside documents and completing study-related forms
Assists with departmental regulatory tasks as assigned by supervisor, including filing and transportation of important documents for delivery or to obtain signature
Participates in the mentorship and training of team members.
Serves as a resource for research personnel regarding clinical trials and compliance information
Participates in protocol start up meetings and close-out visits.
Administrative Research Functions:
Schedules and participates in routine monitoring. Provides sufficient, appropriate, and timely responses to sponsor queries
Generates reports and spreadsheets from database
In consultation with the research nurse/clinical coordinator and PI, initiates annual or IRB Continuing Reviews, Investigational New Drug (IND) reports, sponsor and other required reports in a timely manner. Reports often require review and submission or signature of the PI.
Attends appropriate departmental meetings and institutional continuing education programs
Shares information and, as requested by supervisor, develops educational presentations for the monthly Clinical Research Group Meeting
Routine Administrative Functions:
Attends appropriate departmental meetings and institutional continuing education programs
Shares information and, as requested by supervisor, develops educational presentations for the monthly Clinical Research Group Meeting
Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process, including but not limited to eligibility and disease processes
Must be able to independently initiate weekly assignments without supervision. Able to understand and respond to telephone conversations with physicians and other members of the health care team, both within and outside the institution. Have excellent verbal and written communication skills.
Demonstrates excellent oral and written communication skills when contacting other institutions, patients, and agencies (i.e., NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email, and/or face to face interactions. Assimilates pertinent information in order to compose written correspondence
Other duties as assigned.EDUCATION:Required: High school diploma or equivalent.Preferred: Bachelor's degree.EXPRIENCE:Required: Four years of related experience. With preferred degree, no experience required.Preferred: Multiple year with Research Case Report Form (CRF) Data entry experience, good communication, reliable, and organized.It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.htmlAdditional Information
Requisition ID: 170437
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 41,500
Midpoint Salary: US Dollar (USD) 52,000
Maximum Salary : US Dollar (USD) 62,500
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Hybrid Onsite/Remote
Pivotal Position: No
Referral Bonus Available?: No
Relocation Assistance Available?: No
Science Jobs: No
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