Senior Coordinator, Clinical Studies - Radiation Oncology Research

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the
nation, and the world through outstanding programs that integrate patient care, research and prevention, and
through education for undergraduate and graduate students, trainees, professionals, employees and the public.
The primary purpose of the Senior Coordinator, Clinical Studies position is to collaborate with the research team
and Principal Investigator (PI) to coordinate clinical trial subject accrual and data management activities for
departmental clinical research. Under the guidance of the Research Nurse Supervisor, the Senior Coordinator,
Clinical Studies will also assist with the supervision of data management staff ensuring that departmental clinical
research is conducted in compliance with institutional policies, the Code of Federal Regulations, and Good
Clinical Practice Guidelines.
Key Functions
ADMINISTRATIVE
 Assists with the development process of research data management staff.
 Assures that policies/procedures of the institution and department are communicated to staff formally and
informally by written and/or verbal means.
 Participates in the development and maintenance of the staff orientation manual. Coordinates initial
staff orientation and acts as lead preceptor for research clinical coordinator staff. Assesses the
effectiveness of training programs, identifies learning needs, and modifies orientation process as
needed. Develops and maintains templates to support staff development and increase clinical trial
effectiveness.
 Serves on the Clinical Research Group (CRG) Process and Policy Committee. In collaboration with the
Clinical Research Group management, reviews current departmental clinical research policies and
processes to ensure relevance. Modifies and/ or develops new guidelines as requested.
 Assists with internal quality assurance audits of clinical research group processes related to data
management and the adherence to relevant departmental policies.
 Shares information and, as requested by the Research Nurse Supervisor, develops educational
presentations for the monthly Clinical Research Group Meeting.
 May be asked to provide coverage for key functions and/or at relevant meetings for the research team.
 Manage several trials, including regional centers
CLINICAL TRIAL MANAGEMENT
 In consultation with the physician and research nurse, assesses patients for eligibility through personal
interviews and medical record review. Responsible for accurate and successful patient recruitment to
assigned protocols.
 Reads protocol and in collaboration with the Research Nurse, develops systems for screening patients.
Assists with the development of source document templates and other documents as needed for
protocols.
 In collaboration with the Principal Investigator (PI), responsible for ensuring the consent is understood,
signed, and processed appropriately.
 Consults with principal investigator (PI) regarding ongoing clinical trial assignments. Works closely
with research nurse to ensure consistency between protocol database and source documentation;
includes generating written queries for missing/deficient source documentation. As needed, obtains
patient charts and outside documents required for protocol compliance.
 Responsible for accurate and timely transcription of study data to paper and/or electronic Case Report
Form (CRF), retrieving information from electronic record, chart, and/or phone call. Requires face-to face interaction with patients. Requires ability to gather relevant information and determine the
appropriate information to report. Requires accurate and prompt patient documentation in the patient's
medical record.
 Knowledge of protocol databases and electronic applications; proficient in the use of Microsoft office
applications and departmental electronic data systems.
 Communicates routinely with intradepartmental, extramural, and industry research collaborators
regarding queries, data entry, database issues, protocol status, and other events
 Schedules and participates in routine monitoring. Provides sufficient, appropriate, and timely responses
to sponsor queries. Participates with activities ensuring preparedness for industry, institutional, and
federal clinical trial audits.
 Preparation of quality reports and metrics for the purpose of grant submissions, budget creation, clinical
trial evaluations, protocol review presentations, data review events, audits, conferences, posters, and
manuscripts as required by the department.
MAINTAINS A LEVEL OF PROFESSIONAL EXPERTISE
 Attends appropriate departmental meetings and institutional continuing education programs
 Plans, designs, and conducts complex professional and ancillary education sessions to ensure
dissemination of new information and policies.
 Demonstrates excellent oral and written communication skills when contacting other institutions,
patients and agencies (i.e. NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email
and/or face to face interactions. Assimilates pertinent information in order to compose written
correspondence.
 Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice
guidelines as well as a comprehensive understanding of the research trial process, including but not
limited to eligibility and disease processes.
 Other duties as assigned.
Education
Required: Bachelor's degree.
Experience
Required: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years 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: 165957
• Employment Status: Full-Time
• Employee Status: Regular
• Work Week: Days
• Minimum Salary: US Dollar (USD) 65,000
• Midpoint Salary: US Dollar (USD) 81,000
• Maximum Salary : US Dollar (USD) 97,000
• 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