Clinical Research Project Manager

RESUME

Sandra Clancy, B.S., CCRC

Ph469-***-**** ; email - *********@*******.***

HOME ADDRESS: **** ********* *****, ******, ** 76210

EDUCATION: B.S., Psychology/Special Education, Northwestern State University, Natchitoches, LA

EMPLOYMENT HISTORY:

05/12 - 12/15: Project Manager, LSUHSC-Shreveport: Under the scope of this position, I am tasked with providing support, expertise, and guidance in multiple areas of the Human Research Protections Program. Independent judgment, initiative, and time management are skills that serve me well in my efforts in collaboration with the various disciplines on the campus; strategic and operational skills are required in the processing and application of federal criteria and appropriate ethical standards to research on our campus. Currently I am responsible for the preparation, negotiation and execution of all contracts for industry-sponsored research on our campus; in addition to the contract, the cost analysis and pre-review of IRB submissions fall under the auspices of my office in order to assure compliance with Institutional policy as well as all applicable laws and regulations. Other tasks that have been assigned under this position have included QA audits, site management, and IRB Analyst.

08/09 to 05/12: Clinical Research Coordinator, The Heart Hospital Baylor Plano: Responsibilities include: review and coordinate new study projects as provided by study sponsors; assist in the development and implementation of study procedures, research documents, and continuity of patient care; coordinates the preparation of all IRB regulatory documents to assure compliance with institutional, federal and state guidelines and regulations that govern research. Other duties as required for the conduct of clinical trials including pre-study implementation through study closure are included in the scope of this position.

07/06 to 08/09: Clinical Research Associate, Epidemiology, St. Jude Children's Research Hospital: Responsibilities include, but are not limited to, abstracting, assembling and organizing research data for St. Jude Life, ACT Transfers, and other projects requiring summation of patient-specific information pertaining to treatment of childhood cancer. Specific duties include the preparation and organization of patient health records for those individuals who have achieved alumnus status and are no longer followed by this institution. This project requires attention to detail and management of continuous data as it is submitted to the Cancer Registry.

11/03 to 07/06: Project Coordinator, Division of Research, Dept. of Medicine, LSUHSC-Shreveport: Responsibilities include the design, implementation and oversight of a variety of programs involved with numerous research projects for the Department of Medicine/Division of Research; to be responsible for coordinating the startup of all clinical trials and associated/required start up functions; to supervise four Coordinators of Medical Service Areas involved with the regulatory administration for the research program; to coordinate the regulatory status of research projects to the research coordinators and provide updates on any changes in protocols and consents.

Additional responsibilities include preparation of training materials and distribution to all research staff, working with the research Project Managers to establish and meet set timelines, study requirements and coordinating recruitment and advertising strategies to meet enrollment obligations.

Further requirements include a working knowledge of all assigned protocols to ensure the validity of the clinical research data, verify patient eligibility, develop, and maintain individual patient research charts. I assist in the preparation of adequate, accurate records pertinent to enrollment, the preparation of case report forms, and supporting data. All IRB required documents, safety reports, annual protocol renewal requests and/or termination reports, development of study-specific informed consents, monitor follow-up letters, and sponsor-related correspondence are included in the scope of this position.

Disciplines of experience include: dermatology, cardiology, oncology, endocrinology, pulmonary, infectious diseases, rheumatology, and nephrology.

11/01 to 11/03: Data Coordinator II, US Oncology, Dallas, Texas: Responsibilities include the preparation of all study-related information from various sites participating in clinical research for retrieval by pharmaceutical sponsors, assisting medical personnel in the implementation of protocols relative to the treatment of cancer, verification of protocol requirements to ensure data submitted is of the highest quality, interacting with site personnel in order to achieve desired objectives and outcomes in terms of meeting accruals, and enrollment, maintaining documentation for quality as well as medical audits, and preparation and coordination of all required documentation such as regulatory and pharmacy records to comply with sponsor and regulatory agencies. Duties also include the training of new research staff regarding the interpretation of protocols and their role in the research project, while organizing and maintaining the collected data into the appropriate case report form. Obtaining and documenting the required Informed Consents.

References and additional work history supplied upon request.

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