This job has expired

Clinical Studies Coordinator

Employer
University of Texas MD Anderson Cancer Center
Location
Houston, Texas
Salary
Competitive
Closing date
Dec 15, 2021

View more

Discipline
Health Sciences
Organization Type
Healthcare/Hospital
You need to sign in or create an account to save a job.
MISSION STATEMENT
The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

SUMMARY

The primary purpose of the Clinical Studies Coordinator is to provide day-to-day management and oversight of the administrative, regulatory, compliance, and/or patient care issues related to the coordination of clinical trials. The Clinical Studies Coordinator will serve as an effective point of contact regarding the status and progress of assigned Theragnostic research trials and studies.

JOB SPECIFIC COMPETENCIES
Daily Operations day-to-day management and oversight of the administrative, regulatory, compliance, and/or patient care issues related to the coordination of clinical trials.
  • Accurately performs scheduling duties withing deadline dates/timeline and withing the standards established by the research study protocol
  • Possesses a working knowledge of diagnostic imaging procedures and theragnostic protocols while applying knowledge of work area to maximize section resources and increase efficiency
  • Demonstrates the ability to develop, maintain and modify templates for patient scheduling
  • Assures that all necessary patient documentation is complete and accurate
  • Conveys information clearly, concisely, accurately and in a professional manner through both written and verbal channels during routine and emergency situations
  • Demonstrates understanding of medical terminology and medical knowledge, as it relates to the operational unit, to identify concerns and achieve section and clinical objectives
  • Demonstrates highly developed organizational skills, ability to multi-task and work in a fast-paced environment
  • Attends and actively participate in scheduled departmental meetings, completes mandatory department in-services and continuing education programs to satisfy all educational requirements.

Coordination
  • Coordination of activities related to initiation and conduct of clinical trials and studies
  • 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.
  • Recording patient information
  • Maintain data necessary for audits
  • Collect or facilitate the collection of specimens as outlined in assigned protocol
  • Develop and maintain database for tracking labs specimens, responses and research tests 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
  • Schedules patient tests, keeping patients informed about scheduled appointments
  • Review protocol documents including abstracts, text & informed consent
  • Register patients on protocols by verifying eligibility/exclusion criteria
  • Assist in obtaining consent
  • Assist in the screening for adverse events
  • Follows patients on studies and maintains knowledge of adverse events. Also, submits information on adverse events to IRB and revises consents
  • 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
  • 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
  • Manage protocols at appropriate intervals and participates in monitoring and audit activities
  • 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
  • Ensures that the conduction of assigned studies is in accordance with Good Clinical Practice, Federal regulation and institutional policies
  • Understand and adhere to the policies and procedures related to conduct of clinical trials and studies

Financial Management
  • Reviews hospital and professional charges to ensure patients &/or Primary Investigator are charged appropriately per protocol.
  • Monitors workqueue for PB registration / insurance errors and bad-debt status. Will research the reason, take appropriate action and resolve when applicable.
  • Performs monthly reconciliation of services including, but not limited to, invoicing for fees for services as indicated on the cost determinations.

Other Duties Other duties may include screening patients for eligibility into clinical protocols, and supporting data entry efforts with the Research Nursing team as well as other needs to fill the Clinical Research Imaging &/or Theragnostic Program needs.

Bachelor's degree. 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. 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
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert