Coordinator, Clinical Studies

Position Title: Coordinator, Clinical Studies

Job Code: 04394

Department: CTRC

Division: Cancer Medicine

Mission Statement

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.

Summary

The Coordinator Clinical Studies collaborates with the research team and principal investigator to provide independent and advanced assessment of both research and patient care services and operational management for clinical trials. Impacts the efficient analysis and timely processing of research protocols and contributes to the care of patients enrolled in designated protocols. Ensures strict adherence to the policies and procedures of the institution. Impacts the successful conduct of research clinical trials, the appropriate evaluation and reporting of these trials, and the reputation of the PI, the department, and the cancer center as a center of excellence for patient-oriented research.

Core Values

Caring Behaviors

• Courtesy: Is respectful and courteous to each other at all times
• Friendliness/Teamwork: Promotes and rewards teamwork and inclusiveness; Is sensitive to the concerns of our patients and our co-workers

Integrity Behaviors

• Reliability: Communicates frequently, honestly and openly
• Accountability: Holds self and others accountable for practicing our values
• 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)

Discovery Behaviors

• Responsiveness: By his/her actions, creates an environment of trust; Encourages learning, creativity and new ideas
• Personal Leadership/Self-Initiative: Helps others to identify and solve problems; Seeks personal growth and enables others to do so

JOB SPECIFIC COMPETENCIES

Clinical Trial Management (Protocol Setup)

• Responsible for the overall effective operation of protocols which involve the collaboration of the CTRC. For designated protocols, provides leadership for effective protocol research sample collection, processing and shipment to sponsor designated labs across the nation and worldwide.
• Manages new protocol start-up process. Participates in site initiation visits (SIV ) to obtain clarification of issues related to sample collection, processing and shipment.
• Collaborates with study sponsors to ensure lab manuals and sample collection kits are developed correctly and are in compliance with the protocol requirements.
• Creates collection sheets in accordance with the protocol requirements.
• Requires considerable exercise of independent judgment, initiative, and a basic knowledge of medical terminology and administrative procedures.

Clinical Trial Management (Protocol Maintenance)

• Collaborates with the research teams and study chair or protocol sponsor regarding protocol amendments, and withdrawals. Monitors revisions and amendments to protocols and revise collection sheets accordingly and timely.
• Coordinate with the research teams and sponsors to ensure lab manuals and sample collection kits are developed correctly and are compliant with the amended protocol requirements.
• Manages industry sponsor relations and acts as a liaison between sponsor representatives and the laboratory team.
• Participates in monitor visits. Performs QA audits to monitor compliance and accuracy of data.
• Manages sponsor queries related to all aspects of research sample collection, processing and shipment on study protocols, including accuracy of time points and quality of final product. Follows through and ensures the resolution of queries in a timely manner and to mutual satisfaction.
• Familiar with the LIMS system (ARMADA). Responsible for kit management for all designated protocols. Ensures stored research samples are properly obtained and managed per protocol.

Laboratory Involvement

• Assists with laboratory management for designated trials.
• Presents new studies to the technical team, provides an overview of each study objective, overall design, and schedule of research assessments.
• Monitors the start-up process and ensures that the technical lab personnel and supervisors are fully knowledgeable of their functions.
• For amendments, incorporate revisions in the collection sheets and ensure that the technical staff are trained in new sampling procedures and/or processing techniques.
• Ensure that airway bills are available for sample shipments.
• Conducts quality control and trial monitoring of all samples collected, processed and shipped that have been entered into the LIMS system.
• Reviews protocol documents including data collection sheets, fax orders, and requisitions for relevant information.

Other duties as assigned

• Requires flexibility in work schedule due to operational requirements. Also, must be able to respond to iPhone/pager after hours/on weekends. Various meetings/work responsibilities outside of set schedule.

COMPETENCIES

Analytical Thinking - Gather relevant information systematically; break down problems into simple components; make sound decisions.

Coach and Develop - Assess strengths and development needs of employees; provide challenging development opportunities; provide relevant, timely feedback; mentor others.

Listen to others - Listen to feedback and input carefully; demonstrate attention to others; acknowledge and listen to differing perspectives in a group.

Service Orientation
Provide service to our stakeholders, including patients, caregivers, colleagues and each other, in a safe, courteous, accountable, efficient and innovative manner to include:

• Promoting inclusiveness and collegiality that demonstrates respect and professionalism to our stakeholders at all times
• Modeling safe, ethical behavior that mitigates risk to the institution through sound business practices, and adherence to MD Anderson's Standards of Conduct, institutional policies and procedures
• Responding to requests in a timely manner while proactively communicating expectations for procedures, service arrival, or project deliverables to stakeholders
• Using the steps to HEAL (Hear, Empathize, Address and Learn) the relationship when service recovery is needed

Customer Focus
Builds and maintains customer satisfaction with the products and services offered by the organization through skills demonstrated in communication, personalization of interaction, regulation of emotions, and proactive problem solving.

Performance Statement Examples

• Presents a cheerful, positive manner with customers either on the phone or in person. Shows interest in, actively listens to and responds in a clear and timely manner to customer's expressed needs.
• Focuses on the customer's results, rather than own. Goes beyond basic service expectations to help customers implement complete solutions through personalized service that anticipates the customer's unspoken needs.
• Delivers services when and where the customer needs them. Explores options when unable to deliver a requested product or service and pursues solutions until the customer is satisfied by addressing the root cause of the issue. Problem solves with patient, family member, care giver or clinical team to aid in proactively resolving issues and concerns.
• Provides to customers status reports and progress updates. Seeks customer feedback and ensures needs have been fully met.
• Talks to customers (internal and external) with a pleasant tone to find out what they need and how satisfied they are with the service. Remains in control of own reactions and responds in a manner that demonstrates appropriate nonverbal cues and complements the customer's emotions in the situation. Recognizes when it is necessary to escalate situations to leadership to ensure customer satisfaction.

REQUIREMENTS

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

Preferred Education: Master's Level Degree

Certification: None

Preferred Certification: none

Experience: Three years' experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. Additional years of related experience and/or education may be substituted on a one to one basis.

Preferred Experience: Experience as a Sr. Research Data Coordinator.

Onsite Presence: Is Required

WORKING CONDITIONS

Frequency

Deadlines
Electrical
Exposure to blood, bodily fluids, and/or tissue
Hazardous Chemicals and Materials
On Call
Sedentary Environment
Wearing Protective Equipment
Working At Heights

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Seldom 3-10%
Occasionally 11-33%
Rarely1-2%

Frequent 34-66%
Occasionally 11-33%
Seldom 3-10%

PHYSICAL DEMANDS

Frequency

Weight

Arm/Hand Steadiness
Balancing
Bending/Stooping
Carrying
Depth Perception
Eye/Hand Coordination
Fine finger movement
Keyboarding
Lifting
Reaching
Tactile Perception
Visual Acuity
Visual Color Discrimination
Walking
Wrist Motion

Seldom 3-10%
Occasionally 11-33%
Occasionally 11-33%
Occasionally 11-33%
Occasionally 11-33%
Occasionally 11-33%
Occasionally 11-33%
Frequent 34-66%
Occasionally 11-33%
Frequent 34-66%
Frequent 34-66%
Occasionally 11-33%
Occasionally 11-33%
Occasionally 11-33%
Frequent 34-66%

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5-10 lbs
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10-20 lbs
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COGNITIVE DEMANDS

Analytical Ability
Appropriate Behavior
Attention to detail
Comprehending
Creativity
Critical Thinking
Following Instructions
Giving and Receiving Constructive Feedback
Interpersonal Skills
Mathematical Skills/Reasoning
Memorizing/Remembering
Multitasking
Oral Communication
Organizing
Problem Solving
Reading Skills/Comprehension
Responding in emergency situations
Selective Attention
Working Alone
Written Communication

Bachelor's degree. 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