Summary

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 Functions

Clinical Trial Management:

Reads protocol and develops systems for managing the patient data.

Responsible for accurate and timely transcription of study data to electronic Case Report Form (CRF), retrieving information from electronic record, chart, and/or phone call. Requires the 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.

Prepares progress updates and study/patient status to the principal investigator (PI) on assigned clinical trials during PI meetings.

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.

Assist clinical studies coordinator and research nurse as needed with obtaining patient charts and outside documents and completing study-related forms.

Responses to data queries within the timeframe specified by the contract or institutional policy.

Assists with departmental regulatory tasks as assigned by supervisor including filing.

Prepares data to meet database lock and other deadlines.

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 the 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.

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.

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 Education: Bachelor's degree

Experience Required - Four years of related experience. With preferred degree, no experience required.

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.html