What are the responsibilities and job description for the Clinical Studies Coordinator position at MD Anderson Cancer Center?
The primary purpose of the Clinical Studies Coordinator is to provide clinical study related coordination including but not limited to data management, patient coordination, and regulatory management for a clinical research lab that focuses on generating and treating cancer patients with antigen specific T-cells in a field called immunotherapy. This person will work directly with research scientists, medical staff and nurses, the FDA, IRB and other regulatory offices, and patients to maintain and ensure the smooth operation of clinical studies within a Phase I study or single patient IND (SPIND).
JOB SPECIFIC COMPETENCIES:
Assist in the collection and evaluation of data:
* Develop and maintain a processing and tracking system for all protocol-related paperwork.
* Develops patient care methodology for protocols, including criteria for patient participation.
* Collects and develops criteria information for protocol submission.
* Make sure all documentation and trials fall under state and institutional regulations, including compliance with IRB and FDA offices
Coordination of activities related to the initiation and conduct of clinical trials and protocols:
* Effectively conducts assigned operations of research protocols.
* Provides all study-related coordination including writing, submission and maintenance and tracking system of protocols and protocol-related paperwork.
* Coordinates FDA submissions for Phase I clinical trials and SPINDs
* Supervise necessary regulatory and clinical data for audits.
* Thorough understanding of clinical research systems such as OnCore, OneConnect, and OneIRB.
* Schedules patient tests, and keeps patients informed about test results and studies.
* Schedules patient pre-trial conditioning and infusions.
* Collaborates with physicians, mid-level practitioners, research nurses, and data managers to document patient care.
* Coordinates with clinical research technicians and GMP facility regarding the scheduling of antigen-specific T cell generation.
* Maintains open communication with the team regarding patient pathology results, scheduling of pre and post-infusion tracking samples, and patient infusion dates.
* Coordinates, evaluates and follows patient participation in clinical trials.
* Follows patients on studies and maintains knowledge of adverse events.
Collect or facilitate the collection of specimens as outlined in assigned protocols:
* Under the supervision of the medical staff and research nurse staff, performs protocol-specific tasks including screening, ordering tests, collecting specimens and studying documentation of patient reported responses
Professional Education/Training:
* Trains other support stall in study coordination.
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.
Preferred: Thorough understanding of protocol submission, maintenance, and compliance with IRB and experience in operation of clinical research protocols. Understands regulatory submissions process for phase 1 cell therapy trials. Understands clinical research study needs for cell therapy phase I trials, including obtaining patient consents and specimen collection during follow up visits.
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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