MD Anderson Cancer Center Coord, Clinical Studies - GI Medical Oncology in Houston, Texas
The Clinical Studies Coordinator provides all study related coordination, including but not limited to data management, patient coordination, and regulatory management for clinical research studies. Impacts clinical trial patients in designated protocols for the Colorectal Moonshot Program. Additionally, this position will impact the quality and accuracy of patient specimens. This person will work directly with the principle investigators, medical staff, research nurses, and pharmaceutical sponsors and monitors.
The department of GI Medical Oncology has a mission to deliver the highest quality patient care by providing the most advanced medical therapies and opportunities to participate in clinical trials, with the goal of improving survival and quality of life. Research scientists are working to find better therapies, as well as more accurate diagnosis and screening procedures to detect GI cancers in their earliest stages.
The salary range is: min-$50,800, mid-$63,500 and max-$76,200.
I. Study Patient Enrollment
Compiles health information on study patients. This process includes searching the past medical records and recording detailed information such as past medical history, previous surgical interventions, chemotherapy or radiotherapy treatments, and con-med history. Acquired information must be completed appropriately and transferred to the electronic medical record system.
Assists in collecting and organizing outside medical records and laboratory results for patients consented on research protocols. Ensures that all the relevant and needed information is available for review and filing. Visually reviews information to be filed in order to classify, file and purge information; scans documents as required.
Takes the responsibility for patients in long term follow-up on research studies. Makes follow-up phone calls or checks ClinicStation for survival data on patients. Additionally employee may be responsible for assuring patients are scheduled to see the investigator if necessary.
Assist other staff with organization of research protocols to include ensuring patient folders are complete and available for the research nurse or assist as directed from responsible staff.
Attends site initiation meetings for relevant studies. Maintains communication with monitors and sponsors regarding the status of patients. Resolves queries and issues related to research protocols.
May assist PI with data review and confirmation to assure readiness for audits, both internal and external.
Meet weekly with PI and staff to review protocol activities. Prepares reports as needed for primary investigator.
Consents patients for other correlative lab studies; documents process accordingly. Notifies appropriate parties of patient registrations.
Administers required surveys and reviews for completeness.
Registers patients into CORe / Epic
II. Biospecimen Collection/Tissue Procurement
Responsible for coordinating blood sampling / biospecimen collection by interacting with the multi-disciplinary teams. This includes identifying, collecting and delivering tissue samples to the lab and other sites for PDX generation
Performs phlebotomy to obtain blood samples from patients in the clinic. Collects biospecimens ordered for the patient and delivers them to the proper laboratory. Processes samples (e.g. centrifuging to obtain plasma, serum, isolating and cryopreserving PBMCs or delivery and processing of immunotherapy samples), labels, pipettes and transfers to appropriate containers ultimately storing specimens at specified temperatures.
Records collection, stores and ships biospecimens per instructions; packages samples such that they arrive at destination in a suitable condition.
Helps to enter, maintain, and oversee the quality and integrity of research sample and immunotherapy tissue sample databases.
When applicable, arranges shipment of sample boxes with a suitable air freight carrier and contacts pharmaceutical company personnel to coordinate shipment and verify receipt of samples. Handles dry ice.
Maintains accurate daily logs of all test samples collected and serves as an information source regarding status of samples collected from patients on specific protocols.
Attends protocol start-up meetings with sponsor company representatives and institutional clinical personnel to assure sample collection procedures and forms are fully understood.
Registers all biospecimen into Tissue Station; Maintains Tissue Station records to accurately reflect tissue use. Maintains biospecimen per federal guidelines.
III. Other Duties
Develops and maintains a processing and tracking system for research studies.
Responsible for preparing appropriate reports for investigator initiated studies. This process includes obtaining information needed by the investigator for publications and presentations. Information such as patient adverse events, time to tumor progression, and long term survival data.
Serves as team leader within the biospecimen collection team, leading by example on how to complete various tasks.
Assists in special projects as assigned.
Required: Bachelor's Degree in Public Health, Healthcare Administration, or related scientific fields.
Preferred: Masters Degree in a related field.
Required: 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-for-one basis.
Preferred: Phlebotomy experience and sample processing (centrifuging to obtain plasma, serum or isolating and cryopreserving PBMCs or delivery and processing of immunotherapy samples)
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