Supervisor, Clinical Studies

Position Title: Supervisor, Clinical Studies

Department: Clinical and Translational Research Center Laboratory (CTRC Lab)

Division: Cancer Medicine

Reports to: Cancer Medicine Department Administrator or designee

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 University of Texas MD Anderson Cancer Center Clinical and Translational Research Center (CTRC) is the dedicated MD Anderson site for complex biologically based new drug development with a focus on first-in-man, Phase I and Phase II studies with rigorous time points and pharmacologic testing. The CTRC provides a unique resource for physician-scientists and clinical investigators to develop new agents for cancer treatment by offering coordination of multidisciplinary research, regulatory compliance, budget development, intensive and time-sensitive monitoring of patients, phlebotomy, prompt accurate specimen processing, storage, tracking and shipment of specimens. Established in 1990, The CTRC laboratory has become one of the largest clinical trial sites in the nation. The department continues to see significant expansion with over 600 active clinical protocols and over 16,000 patient visits annually.

The primary purpose of the Supervisor, Clinical Studies Coordinator position is to provide supervision and guidance to the Clinical Study Coordination team to ensure successful performance of the CTRC laboratory in alignment with the institutional needs for the support of clinical research and integrated direct patient care activities. Performs some or all the functions of a Clinical Studies Coordinator as needed. Ensures strict adherence to federal, state, institutional and departmental guidelines policies and procedures.

Core Values

Caring Behaviors

• 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.

Integrity Behaviors

• 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.

Discovery Behaviors

• 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.

Key Functions

1. Clinical Trial Management/ Supervision

• Provides supervision, mentoring and guidance to Clinical Study Coordination (CSC) Team to ensure compliance with all standards, policies, and quality measures for assigned protocols.
• Develops, implements and maintains Standard Operating Procedures to ensure effective and efficient operations.
• Assigns new studies to team members and manages team workload and efficiency. Establishes data-driven productivity measures for CSC team. Ensures adequate coverage during absences or staffing shortages.

• Collaborates with the Quality Assurance Specialist and CTRC Laboratory Manager to investigate and analyze queries, incidents and Safety Intelligence Reports to develop action plans to improve and sustain laboratory performance and ensure protocol compliance.

• Coordinates with the research teams and laboratory staff to ensure the data collection sheets and lab instructions are accurate.
• Assists with the review of various protocols related to pharmacologic sampling, processing and shipment that require the CTRC Laboratory involvement.
• Maintains open communication with departments and their regulatory staff to be aware of upcoming new protocols and amendment changes that require CTRC Laboratory involvement.

• Promotes and encourages communication and teamwork across all staff within the CTRC laboratory, the division and across the institution, including the CTRC liaisons from various departments.
• 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 to ensure protocol compliance.
• Participate in conducting department training sessions to ensure protocol compliance and dissemination of new information and policies.

1. Clinical Protocol Activities

• Participate in activities related to initiation and conduct of clinical trials (protocol review, site-initiation visits and tours and feasibility questionnaires).
• Coordinate protocol-specific clinical tasks as needed (training sessions, 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).

1. Personnel Management

• Participates in the interview and selection process for clinical research personnel in assigned area. Effectively evaluates applicants after conducting in-depth and inclusive interviews.
• Develops and maintains a training program for CSC team. Coordinates orientation, training and development of new team members
• Communicates and administers policy and procedures, including counseling and disciplinary actions
• 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.
• Provides development opportunities and ongoing feedback to employees to include timely completion of administrative staff and classified employees each evaluation period
• Participate in the training and development of personnel in the clinical research area, with emphasis on effective orientation and continuing education.
• 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.

Core Competencies

• IC - Analytical Thinking:
  • Gather relevant information systematically;
  • Break down problems into simple components; and
  • Make sound decisions.
• IC - Oral Communication:
  • Express ideas clearly and concisely in groups and one-to-one conversation; and
  • Create an environment with open channels of communication.
• IC - Written Communication:
  • Convey information clearly and concisely through both formal and informal documents;
  • Adapt writing style to fit the audience.
• IC - Professionalism:
  • Employee demonstrates commitment to collaborative professional relationships with physicians and all members of the health care team;
  • Demonstrates a high level of responsibility, ethical practice, sensitivity to a diverse patient population and adherence to legal and regulatory requirements;
  • Demonstrates a commitment to excellence (i.e. proper hand washing practices) and on-going professional development.
• IC - Build Relationships:
  • Initiate, develop, and manage relationships and networks; and
  • Show sincere interest in others and their concerns.
• IC - Innovative Thinking:
  • Approach problems with curiosity and open-mindedness; and
  • Offer new ideas, solutions and/or options.

Education

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

Preferred: Master's Degree in related field.

Experience

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: Two years of clinical studies management experience in CTRC.

Supervision

Received: Cancer medicine Department Administrator or designee

Given: Clinical Study Coordinators

Working Conditions

This position requires:

Working in Office Environment

No

Yes

Working in Patient Care Unit (e.g. Nursing unit; outpatient clinic)

No

Yes

Exposure to human/animal blood, body fluids, or tissues

No

Yes

Exposure to harmful chemicals

No

Yes

Exposure to radiation

No

Yes

Exposure to animals

No

Yes

Physical Demands

Indicate the time required to do each of the following physical demands:

Time Spent

Never

0%

Occasionally

1-33%

Frequently

34-66%

Continuously

67-100%

Standing

Walking

Sitting

Reaching

Lifting/Carrying

Up to 10 lbs

10lbs to 50 lbs

More than 50 lbs

Pushing/Pulling

Up to 10 lbs

10lbs to 50 lbs

More than 50 lbs

Use computer/keyboard

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 to include three years of lead or supervisory experience. Successful completion of the LEADing Self Accelerate program may substitute for one year of required supervisory or management experience. Must pass pre-employment skills test as required and administered by Human Resources. 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