MD Anderson Cancer Center Clinical Studies Coordinator - Endocrine Neoplasia and HD in Houston, Texas

Clinical Studies Coordinator - Endocrine Neoplasia and HD

Location: United States, Texas, Houston, Houston (TX Med Ctr) at

Research at

Internal Medicine 600642

Requisition #: 116616

To provide clinical coordination, implantation, and monitoring of patients enrolled in clinical research protocols. The Clinical Studies Coordinator will serve as an effective point of contact regarding the status and progress of assigned Endocrine Neoplasia and HD trials and studies.

Coordination of activities related to initiation and conduct of clinical trials and studies.

Obtain Research Charge Tickets for protocols and assure appropriate use for billing to sponsored study accounts is accurate.

Timely notification of patient on study to patient access coordinator and PBS.

Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.

Coordinate, evaluate, and follow the patient’s participation in clinical settings. Collaborate with the multidisciplinary team as necessary to document patient care, achieve objectives of clinical trials and studies, and maintain patient safety.

Instruct co-workers in allied fields in procedures for recording patient information.

Maintain data necessary for audits.

Collect or facilitate the collection of specimens as outlined in assigned protocol

Process samples, labels, pipettes, and transfer to appropriate containers ultimately storing specimens at specified temperatures.

Develop and maintain database for tracking specimens with high level of accuracy.

Serve as an information source regarding status of samples collected from patients on given protocols for PI and sponsors.

Understand and adhere to the policies and procedures related to conduct of clinical trials and studies

Direct support to clinical trial and study research protocols.

Review protocol documents including abstracts, text & informed consent

Register patients on protocols by verifying eligibility/exclusion criteria;; communicate registration information to sponsor as directed by PISchedule patient tests; keep patients informed about test results & studies

Assist in obtaining consent

Act as liaison with patients, physicians & research staff in providing administrative & patient care services for the coordination of studies. If required for multi-center trials and studies, maintain contact with other institutions & coordinate data

Complete case report forms timely & accurately

Assist in the screening for adverse events

Follow patients on study for safety monitoring; adhere to institutional policies for safety & infection control

Monitor protocol compliance by coordination of protocol-specific lab, radiographic, & clinical evaluation of patients. Act as lead in data collection for outside films, surgical, pathology & lab reports per protocol & submitting specimens/films

Retrieve protocol-related data as documented in the medical record and accurately enter it into a computerized database or on a handwritten case report form.

Generate protocol summary reports and user-generated data reports as requested.

Provide assistance upon request for the preparation of technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.

Understand and adhere to the policies and procedures related to conduct of clinical trials and studies

Assist PI as needed to complete annual reviews

Coordination of regulatory correspondence on clinical research studies

Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).

Complete forms and comply with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.

Understand and adhere to the policies and procedures related to conduct of clinical trials and studies

Other duties as assigned.

Required: Bachelor's degree in Public Health, Healthcare Administration or related scientific field. Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. Additional years of related experience and/or education may be substituted on a one to one basis.

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.