Coordinator, Clinical Research Program (Regulatory Submissions)

Location
Houston, Texas
Salary
Competitive
Posted
April 09 2021
Ref
139097
Organization Type
Healthcare/Hospital
Summary

The primary purpose of the Coordinator, Clinical Research Program position is to provide administrative and patient care services for the coordination of research studies in the Department of GI Medical Oncology.

Key Functions

Strategic Planning

Administrative Management of Clinical Trials
  • Manages administrative/regulatory aspects of research trials including federal and pharmaceutical funded protocols, through all components of a study.
  • Work with study Principal Investigator (PI) by providing administrative support to develop, implement and complete research studies.
  • Independently prepares protocol documents that comply with regulatory and institutional requirements.
    Works with study sponsors and/or Clinical Research Organizations (CROs)) to develop budget documents that conform to both MD Anderson and Sponsor requirements.
  • Submits protocols to the Office of Protocol Research for Clinical Research Committee and IRB review.
  • Responds on behalf of PI as appropriate to comments from protocol reviewers.
  • Coordinates activities associated with site start-up and overall financial trial management.
  • Assists PI as appropriate with preparation of responses to CRC and/or IRB.
  • Acts as a liaison with private industry pharmaceutical companies to aid in the completion of ICD language appropriate for clinical trials.
  • Ensures that all reviews are addressed to the satisfaction of the reviewers.
  • Develops and maintains a processing and tracking systems for protocol related paperwork.
  • Creates, updates, and maintains organizational files which include all pertinent correspondence and information regarding regulatory activities for GIMO clinical trials.
  • Maintains an up-to-date status report and creates summary reports as requested for supervisor, PI, and/or management staff.


Training, Compliance and Education
  • Attends training classes concerning maintaining clinical trials documents according to departmental SOPs as well as Federal Regulations.
  • Attends training classes concerning the research regulatory process and administrative management of clinical trials, including submissions to the CRC and IRB.
  • Assists with creating presentations/ visual aids for adjunct staff concerning the regulatory aspect of clinical research trials administration.
  • Assists with creating and presenting programs/in-services for faculty and staff related to the clinical research administrative process.
  • Ensures compliance with Good Clinical Research Practice standards.
  • Attends in-services, departmental meetings, mandatory training, and/or other events to remain abreast of new policies/procedures affecting the conduct of protocols.
  • Disseminates pertinent information to other team members. Participates in the development of departmental policies and procedures related to protocol research.
  • Assists in the development of in-service educational events for GIMO team members.
  • Maintains knowledge of clinical trials process
  • Orients new faculty/support personnel on department's clinical trials research infrastructure and procedures.


Maintenance of Integrity of Clinical Trials
  • Processes budget and contract changes for protocol amendments.
  • Reviews protocols, amendments, and ancillary documents for discrepancies and/or lack of clarity. Works with PI and/or Sponsor to resolve these.
  • Prepares and submits various reports to sponsors, investigators, regulatory authorities, and Manager, Clinical Protocol Administration and any others deemed necessary.
  • Assists with strategic and long-range planning of departments' clinical trials program. This includes coordination of weekly clinical research review meetings and also ad hoc meetings for department chair and faculty to review new protocols for potential participation.
  • Collaboratively works with all department clinical faculty to provide support for clinical trials goals.


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

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