MD Anderson Cancer Center Sr Coord, Clinical Studies - Cancer Medicine Research Admin in Houston, Texas

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2017 rankings. It is one of only 49 comprehensive cancer centers designated by the National Cancer Institute.

The Sr Clinical Studies Coordinator provides independent and advanced patient care services and operational management for clinical trials.

The salary range is: min-$59,600, mid-$74,500 and max-$89,400.

KEY FUNCTIONS

  1. Coordination and oversight of activities related to initiation and conduct of Strategic Alliance clinical trials.

· Work with PI and Physicians in referring departments to identify potential patients for studies.

· Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.

· Coordinate, evaluate, and follow the patient's participation in clinical settings. Provide collaborative oversight for the multidisciplinary team as necessary to document patient care, achieve objectives of clinical trials, and maintain patient safety.

· Understand and adhere to policies and procedures related to conduct of clinical trials.

· Provide leadership for the overall effective operation of designated protocols, which includes development, design, and resolution of operations and issues in collaboration with the DoCM team, Strategic Industry Ventures team, central office personnel, principal investigator and/or study sponsor.

  1. Coordination of regulatory correspondence on clinical research studies.

· Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).

· Complete forms and comply with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.

· Understand and adhere to policies and procedures related to conduct of clinical trials.

  1. Direct support to clinical trial research protocols.

· Review protocol documents including abstracts, text and informed consent for relevant information.

· Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies.

· Assist in obtaining consent for studies.

· Register patients on research protocols by verifying eligibility/exclusion criteria and entering patients and data into required database (per protocol).

· Communicate necessary registration information to the department personnel and the sponsoring drug company as directed by the PI.

· Schedule, or assist with scheduling, screening assessments.

· As applicable to clinical activities, complete case report forms in a timely and accurate fashion.

· When specifically requested may be asked to provide support for labor-intensive protocols by assisting in coordination of protocol-specific scheduling, following patients while on study for safety monitoring, facilitate the collection of specimens as outlined in the protocol, and scheduling patient tests.

· Understand and adhere to policies and procedures related to safety, infection control and conduct of clinical trials.

  1. Oversee, coordinate, and participate in the collection and evaluation of data for principal investigators.

· Monitor the retrieval of protocol-related data as documented in the medical record and ensure accurate entry into computerized database.

· Generate data reports, protocol summary reports, and user-generated data reports as requested.

· Assist upon request with preparation of technical reports, abstracts, posters and manuscripts.

· Understand and adhere to policies and procedures related to conduct of clinical trials.

· Participate in maintaining data necessary for audits and assists with audit responses as requested.

· Additional projects, as assigned.

  1. Training and mentoring

· Train and mentor new study coordinators and data coordinators to perform the functions delineated in their position descriptions.

· Assist with supervisory functions such as counseling employee in regard to institutional policies and procedures.

· Provide input for performance evaluations.

· Provide training and guidance with regard to policies and procedures that are related to conduct of clinical trials.

· Monitor accuracy compliance by study coordinators and data coordinators by performing QA audits.

· Conduct department training sessions to insure protocol compliance and dissemination of new information and policies.

  1. Other duties as assigned.

MARGINAL FUNCTIONS:

Ability to organize, prioritize and focus on tasks is essential. Communicates professionally with colleagues, is respectful of individual differences, and resolves issues quickly. Position will require frequent interaction with physicians, faculty and study teams in multiple departments. Attends protocol meetings and coordinates activities with enrolling departments.

The performance for all expected outcomes is measured by observation by supervisor, reports from physicians and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress. The position also requires the ability to anticipate needs, to recognize situations requiring assistance, to refer or perform any necessary tasks, and to comprehend the goals of the program. The position requires the ability to take initiative in making decisions and taking actions to further these goals. Performs other duties as required.

Must be able to read, interpret, and process large quantities of printed information. Must possess the ability to be clearly understood by verbal communication in face-to-face encounters and by telephone, read printed and written data, assimilate pertinent information in order to compose written correspondence. Must have a strong command of the English language and be able to communicate well verbally and in writing. Must be able to understand verbal and written directions. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis. Must be able to respond and assist other employees and visitors, as required.

EDUCATION

Required: Bachelor's degree in Public Health, Healthcare Administration or related scientific field.

EXPERIENCE

Required: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field -OR- three years of required experience and two years experience as a Coordinator, Clinical Studies at M. D. Anderson. May substitute required education degree with additional years of equivalent experience on a one to one basis.

Preferred: MD Anderson Cancer Center Clinical Studies Coordinator experience that includes consenting patients, working with multiple teams and familiarity with EPIC is a plus.

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