Clinical Studies Coordinator- Breast Medical Oncology

1. E nsures that the implementation of assigned s tudies is in accordance with Good Clinical Practice, Federal regulations and institutional policies. Under the supervision of m edical staff, assists the inv e s t igator in the overall conduct of ass i gn e d clinical trials t h r ough the following activities:
   • participates in departmental protocol review
   • assists with protocol and consent revi s ions as neede d ,
   • assists with the submission process as neede d ,
   • Actively participat e s in p r otoc o l meetings, s uch as inv e s t i gator and initiat i on m ee t in g s
   • manages protocols at appropr i ate intervals and participates in monitoring and a udit activitie s .
   • Appropriately submits information regarding adverse events to the IRB
   • coordinates, evaluates, and d oc u men t s patient participation in clinical trials.
   • Effectively follows patients on protocol by maintaini n g knowledge of their adverse events and response to treatment.
   • Appropriately documents findings in the medical record in collaboration with physician s , mi d - level provider s , research nurses, a n d data managers.

1. Performs protocol-specific duti e s under the supervision of the protocol Phy s i ci a n Investigator to meet the protocol requirements and compliance includin g , but not l i mited to:
   • Screening and determination of eligibility of potential new patients
   • assisting in the informed consent pr o cess
   • schedules, tracks, and performs protoco l - specific tests a nd procedures
   • performs data entry for assigned r e se a rch studi e s focusing on continuous patient follow-up
   • assist the investigator in data file preparation
   • participates in data review meetings as required by t h e department

1. Prepares s pecific protocol re p orts and analysis to aid decisions regard i ng therapeutic efficacy and to assist in manuscript preparation and g rant s ubm i s s io n s.

1. Duti e s may also include phlebotomy and processing of specimens. Coordinates the acquisition of res e a rch b l ood and tissue samples. Visually monitors, ma n ages, a nd o r ders the consumable lab supplies necessary to meet protocol requiremen t s for r e se a rch specimens. Maintains and man a ges documentation of research s pecime n s and research sup p l i e s. Assists in the mai n t en a nce of Joint Commission standards for lab supplies.
2. Assists with the development and submis s ion of research milestone logs in a timely manner and in accordance with the departmental and i n s t itut i on a l policies. Ensures that research related questions are answered as requested by the departmental financial staff for reconciliation of sponsored study accounts.

1. Provides guidance and instruction to research support staff as need e d to promote protocol compliance in accordance with federal and institutional standards. C o mmunicates with clinical staff to ensure protocol patient safety.
   • E x ample:
     1. Participates as needed in the orientation of new staff members
     2. Assists the project leads with the writing and pr e senta t ion of technical reports and presentation materials.
     3. Initiates Self Audits

1. Collaboration/Clinical Trial Management:
   • Timely management of Tumor Measurement assessment, QIAC ordering, off site meetings with radiology collaborator.
   • Participation in ongoing toxicity meetings with PI's, discussion of all SAE's and concerning AE's. Participates in weekly education meetings, bi-weekly staff meetings, regulatory meetings, and any educational opportunity meeting when available.
   • SAE reporting completed within sponsor and MDACC guidelines
   • Clinical Content Template (CCT) creation for new protocols and amendments per department policy including collaboration with pharmacy.
   • Provide clinical coverage for other colleagues and follow the process for time off including providing adequate written and oral coverage reports

1. Other duties as assigned

Required Degree: Bachelor's degree.

Required Experience: 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