The primary purpose of the Coordinator, Clinical Studies position is to collaborate with the research team and Principal Investigator (PI) to coordinate clinical trial subject accrual and data management activities for departmental clinical research, specifically for the Minimal Risk Team. Under the guidance of the Supervisor, Clinical Studies, the Coordinator, Clinical Studies will also assist with ensuring that departmental clinical research is conducted in compliance with institutional policies, the Code of Federal Regulations, and Good Clinical Practice Guidelines.
KEY FUNCTIONS:
ADMINISTRATIVE:
Assures that policies/procedures of the institution and department are communicated to staff formally and informally by written and/or verbal means.
In collaboration with the Clinical Research Group management, reviews current departmental clinical research policies and processes to ensure relevance. Modifies and/or develops new guidelines as requested.
CLINICAL TRIAL MANAGEMENT
In consultation with the physician and research nurse, assesses patients for eligibility through personal interviews and medical record review. Responsible for accurate and successful patient recruitment to assigned protocols.
Reads protocol and develops systems for screening patients. Assists with the development of source document templates and other documents as needed for protocols.
In collaboration with the Principal Investigator (PI), responsible for ensuring the consent is understood, signed, and processed appropriately.
Consults with principal investigator (PI) regarding ongoing clinical trial assignments. Ensures consistency between protocol database and source documentation; includes generating written queries for missing/deficient source documentation. As needed, obtains patient charts and outside documents required for protocol compliance.
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. Requires face-to-face interaction with patients. Requires ability to gather relevant information and determine the appropriate information to report. Requires accurate and prompt patient documentation in the patient’s medical record.
Knowledge of protocol databases and electronic applications; proficient in the use of Microsoft office applications and departmental electronic data systems.
Communicates routinely with intradepartmental, extramural, and industry research collaborators regarding queries, data entry, database issues, protocol status, and other events
Provides sufficient, appropriate, and timely responses to sponsor queries. Participates with activities ensuring preparedness for industry, institutional, and federal clinical trial audits.
MAINTAINS A LEVEL OF PROFESSIONAL EXPERTISE
* Attends appropriate departmental meetings and institutional continuing education programs.
* Plans, designs, and conducts complex professional and ancillary education sessions to ensure dissemination of new information and policies.
* 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.
* 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.
Other duties as assigned.
EDUCATION: Required: Bachelor's degree.
Preferred: Master's degree.
EXPERIENCE: Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience.
Experience Preferred - Research Consenting and Patient Management Experience.
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
