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

1. Responsible for the overall effective operation of protocols which involve the collaboration of the clinical research services laboratories. This includes the development, design and resolution of operational issues in collaboration with the principal investigator or study sponsor. For designated protocols, provides leadership for effective protocol research sample collection, processing and shipment to sponsor-designated labs across the nation and worldwide. Develops SOPs for key processes and procedures for the effective management of clinical trial sampling. Prepares 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.
   
   2. Manages new protocol start-up process. Participates in site initiation visits (SIV), audits and monitor visits, obtains clarification of outstanding issues related to sample collection, processing and shipment, and captures all the information addressed in draw sheets and team presentations. Collaborates with study sponsors to ensure lab manuals are developed correctly and are in compliance with protocol requirements. Creates collection orders in accordance with protocol requirements. 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.
   
   3. Collaborates with department faculty and study chair or protocol sponsor regarding protocol amendments, and withdrawals. Develops and maintains a tracking system for monitoring revisions and amendments to protocols and revise collection sheets accordingly and timely. Incorporate revisions in the collection sheets and ensure that the CIT team is trained in new sampling procedures and/or processing techniques. Collaborates with data coordinators, research nurses, supervisor and/or managers to document study and patient care activities. Provides administrative support to departmental protocol/program managers. Requires considerable exercise of independent judgment, initiative, and a basic knowledge of medical terminology and administrative procedures.

Collaboration and Budgets

4. Collaborates with PIs to develop sample processing protocols and recommends best practices to achieve project goals. Compiles protocol data for manuscript submission.

5. Manages industry sponsor relations and acts as a liaison between sponsor representatives and the laboratory team. 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. Maintain a query database of all the queries received from industry sponsors such as ECG, bone marrow, PK, blood samples, urine, and so forth.

Training and Other

Assists laboratory management with supervisory functions, participates in the technical staff evaluation process. Provides guidance and training to department's clinical research team: research nurses, clinical studies coordinators, and data management group in research study's objectives, overall design, and specimen processing techniques. Orients and trains new CITs, Sr. CITs, and supervisors in established sample collection, processing, storage and shipment procedures

Other duties as assigned

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 FocusBuilds 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 Coordinator, Clinical Studies.

Onsite Presence: Is Required

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