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The primary purpose of the Clinical Studies Coordinator is to provide all study related coordination for a position supporting Melanoma Medical Oncology and Nephrology, including but not limited to data management, patient coordination, and regulatory management for a clinical research lab that focuses on generating and treating stage 4 Melanoma 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 the clinical trial.

Assist in the collection and evaluation of data

• Develops and maintains 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 the state and institutional regulation, including compliance with IRB and FDA offices.

Coordination of activities related to 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 and supervise necessary data for audits.

• Schedules patient tests, 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 lab manager regarding scheduling of cell generation.

• Maintains open communication with clinical research technicians and lab manager 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.

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

• Under supervision of the medical staff and research nurse staff, performs protocol-specific tasks including screening, ordering tests, collecting specimens and study documentation of patient reported responses.

Professional Education/Training Trains other support stall in study coordination.

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.

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

Additional Information

• Requisition ID: 167626

• Employment Status: Full-Time

• Employee Status: Regular

• Work Week: Day/Evening

• Minimum Salary: US Dollar (USD) 55,500

• Midpoint Salary: US Dollar (USD) 69,500

• Maximum Salary : US Dollar (USD) 83,500

• FLSA: non-exempt and eligible for overtime pay

• Fund Type: Soft

• Work Location: Hybrid Onsite/Remote

• Pivotal Position: No

• Referral Bonus Available?: No

• Relocation Assistance Available?: No

• Science Jobs: No

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