MD Anderson Cancer Center Supervisor, Clinical Studies in Houston, Texas
Position Title: Supervisor, Clinical Studies
Department: Clinical and Translational Research Center Laboratory (CTRC Lab)
Division: Cancer Medicine
Reports to: Assistant Director or designee
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 Supervisor, Clinical Studies Coordination position is to supervise, plan, and provide advanced administrative and patient care services for the coordination of clinical trials. Conducts training and mentors staff. Performs some or all the functions of a Clinical Research Program Coordinator. Responsibilities include, but are not limited to: overall clinical trial coordination, implementation, quality control and monitoring of the collection, processing, storage and shipping process of laboratory samples in the CTRC Laboratory. Ensures strict adherence to federal, state, institutional and departmental guidelines policies and procedures.
· Courtesy: Is respectful and courteous to each other at all times; Gives full attention to others minimizing distractions; Does not gossip or air frustrations inappropriately; Uses a respectful/professional tone of voice.
· Friendliness/Teamwork: Promotes and rewards teamwork and inclusiveness; Is sensitive to the concerns of our patients and our co-workers; Expresses awareness of others' experiences and views; Listens to patients and coworkers' needs and empathizes with them; Is aware of and respects individual differences, such as age, gender, ethnicity, physical ability, sexual orientation, religion, culture, background and experiences; Demonstrates collegiality to others in an effort to create a cooperative and collaborative environment.
· Reliability: Promotes and adheres to MD Anderson's Standards of Conduct in addition to all applicable institutional policies and procedures; Communicates time expectations for tests, procedures, or service arrival, or project deliverables to patients and coworkers; By his/her actions, creates an environment of trust; Adheres to attendance policy by timely reporting to work and returning from breaks; Admits when wrong, apologizes and takes steps to resolve a situation.
· Safety: Notices a safety concern and brings it to someone's attention; Models safe behaviors (wears badge, washes hands, keeps work area clean and orderly); Mitigates risk to the institution through sound business practices; Demonstrates ethical and personal responsibility in work and behavior.
· Responsiveness: Encourages learning, creativity, and new ideas; Responds to requests from others in a timely manner; Offers help before being asked; Provides help to patients and coworkers that may be outside of job responsibilities (does not say, "It's not my job."); Looks for new and better ways of doing things.
· Personal Leadership/Self-Initiative: Helps others to identify and solve problems; Seeks personal growth and enables others to do so; Leads by example; Actively encourages others to contribute ideas; Holds self and others accountable for practicing our values.
- Clinical Trial Management/ Supervision
Provide overall coordination of clinical trials which require pharmacologic sampling, processing and/or shipment in the CTRC Laboratory.
Coordinate with the research teams and laboratory staff to assure the data collection sheets, fax orders, schedules and lab instructions are accurate.
Assist with the review of various protocols related to pharmacologic sampling, processing and shipment that require the CTRC Laboratory involvement. Ensures that a Utilization Request is submitted and laboratory details are provided for review.
Assist in the development of data collection sheets and criteria information for various protocols. Building collection details into the lab database
Supervise protocol-related research activity of the Study Coordination Team to assure compliance to all standards, policies, and quality measures for assigned protocols.
· Maintain open communication with departments and their regulatory staff to be aware of upcoming new protocols and amendment changes that require CTRC Laboratory involvement.
· Oversee activities of clinical trials personnel to provide guidance, correction when needed, and coverage when short-staffed; to include day of collection and batch sample shipments and kit inventory management for direct reports.
· Work with the CIT Supervisor and Laboratory Coordinator to ensure protocol compliance; sample collection, processing and shipment.
Coordinate and participate in the interview and selection process for clinical research personnel in assigned area.
Provide training and mentoring for new study coordinators.
Participate in management of departmental clinical research activities and assigned personnel, with emphasis on effective utilization of resources. Assist with appropriate workload assignments (staffing model) through regular communication with the Assistant Director.
Complete performance evaluations of personnel directly supervised. In addition to working with HR on staff related issues, to include disciplinary action and revisiting performance expectations.
Communicate and administer departmental and institutional policy and procedures for personnel in the clinical research area.
- Clinical Protocol Activities
· Coordinate activities related to initiation and conduct of clinical trials (protocol review, site-initiation visits and tours and feasibility questionnaires).
· Participate in protocol-specific clinical tasks as needed. (training sessions via WebEx and/or conference calls, monitor and audit visits and query resolution)
· Assist the research teams with Protocol Start-Up (confirm kit receipt, status of data collection sheets)
· Attend and address complex issues as they arise with internal/external clients (monitors/sponsors/departments).
- Professional Development
Provides in-service/training to staff with regard to clinical protocol coordination and management of research sample collection, processing and shipment per protocol requirements. Provides supervision of research support staff (Study Coordination and Protocol Analysis Teams) to ensure protocol compliance.
Participate in the training and development of personnel in the clinical research area, with emphasis on effective orientation and continuing education.
Participate in conducting department training sessions to ensure protocol compliance and dissemination of new information and policies.
Mentor and encourage clinical research staff to develop through participation in professional organizations, serving on committees, attending journal presentations, seminars, or conferences.
Serves as a preceptor and is responsible for training new research staff on processes and procedures related to coordination of clinical trials.
Other duties as assigned.
The performance for all expected outcomes is measured by observation of the Assistant Director or designee, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress. The position also requires one to anticipate needs, to recognize situations requiring assistance and have the ability to refer or perform necessary tasks. Requires flexibility in work schedule due to operational needs. Also, must be able to respond to emails/calls/pages after hours and/or on weekends. Attend various meetings/work responsibilities outside of set schedule.
· IC – Analytical Thinking:
o Gather relevant information systematically;
o Break down problems into simple components; and
o Make sound decisions.
· IC – Oral Communication:
o Express ideas clearly and concisely in groups and one-to-one conversation; and
o Create an environment with open channels of communication.
· IC – Written Communication:
o Convey information clearly and concisely through both formal and informal documents;
o Adapt writing style to fit the audience.
· IC – Professionalism:
o Employee demonstrates commitment to collaborative professional relationships with physicians and all members of the health care team;
o Demonstrates a high level of responsibility, ethical practice, sensitivity to a diverse patient population and adherence to legal and regulatory requirements;
o Demonstrates a commitment to excellence (i.e. proper hand washing practices) and on-going professional development.
· IC – Build Relationships:
o Initiate, develop, and manage relationships and networks; and
o Show sincere interest in others and their concerns.
· IC – Innovative Thinking:
o Approach problems with curiosity and open-mindedness; and
o Offer new ideas, solutions and/or options.
Required: Bachelor's Degree in Public Health, Healthcare Administration or related scientific field.
Preferred: Master's Degree in related field.
Required: Six years experience with research studies or direct patient care obtained from nursing, data gathering or related field to include 3 years in a lead or supervisory capacity. May substitute required education degree with additional years of equivalent experience or completed years of college on a one-to-one basis.
Preferred: Clinical studies experience at MD Anderson..
Received: Assistant Director or designee.
Given: Directly to staff assigned to the Study Coordination and Protocol Analysis Team.
This position requires:
Working in Office Environment
Working in Patient Care Unit (e.g. Nursing unit; outpatient clinic)
Exposure to human/animal blood, body fluids, or tissues
Exposure to harmful chemicals
Exposure to radiation
Exposure to animals
Indicate the time required to do each of the following physical demands:
Up to 10 lbs
10lbs to 50 lbs
More than 50 lbs
Up to 10 lbs
10lbs to 50 lbs
More than 50 lbs
Bachelor's degree. Six years experience with research studies or direct patient care obtained from nursing, data gathering or related field to include three years in a lead or supervisory capacity. 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 and three years of supervisory 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
Requisition ID: 130082
Employment Status: Full-Time
Employee Status: Regular
FLSA: exempt and not eligible for overtime pay
Work Week: Days
Fund Type: Soft
Pivotal Position: Yes
Minimum Salary: US Dollar (USD) 68,800
Midpoint Salary: US Dollar (USD) 86,000
Maximum Salary : US Dollar (USD) 103,200
Science Jobs: Yes