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Allied Health
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GI Medical Oncology 231100
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143068 Requisition #
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SUMMARY

The primary purpose of the Supervisor, Clinical Studies (regulatory submissions) position is to Supervise, plan, and conducts protocol operations. Impacts research protocols and the patients enrolled in designated protocols.

 

JOB SPECIFIC COMPETENCIES
 

Personnel Management  •     Participates in the management of departmental clinical research activities and staff.
•             Assign protocols to staff and monitor accuracy compliance of staff.
•             Coordinates and participates in the interview and selection process and evaluates staff.
•             Participates in the training and development of staff.
•             Designs and facilitates implementation of new processes.
•             Manage and coordinate staff work and assist staff by answering questions and cascading down changes in the budget procedures.
•             Establish staff performance standards and monitoring progress toward meeting overall objectives.
•             Develop individual staff objectives consistent with departmental goals and operating through the department structure
•             Identify opportunities for professional development of staff.
•             Participate in other aspects of departmental management as requested.
•             Participate in regular meetings with staff to review workload productivity, current events, problems and potential areas of concern.
•             Conduct QA/QC checks of prior work performed to ensure accuracy and identify areas of improvement.

 

 

Administrative Management of Clinical Trials  • Responsible for overall supervision and management of all assigned trials for the GIMO department
•             Manage and monitor assigned projects related to the document and information systems and processes and the submission assembly & processes at regular intervals. Assures that all research conducted in the department complies with the Institutional Review Board (IRB) or federal guidelines.
•             Work with study Principal Investigator (PI) by providing administrative support to develop, implement and complete research studies. Submits protocols to the Office of Protocol Research for Clinical Research Committee and IRB review.
•             Responds on behalf of PI as appropriate to comments from protocol reviewers. Assists PI as appropriate with preparation of responses to CRC and/or IRB. Ensures that all reviews are addressed to the satisfaction of the reviewers.
•             Acts as a liaison with private industry pharmaceutical companies to aid in the completion of ICD language appropriate for clinical trials.
•             Develops and implements standard practices, operating procedures and policies, reporting, analysis and auditing of clinical research finance to ensure compliance with institutional and regulatory requirements.
•             Develops and manages the department implementation of systems, policies and procedures affecting the submission, review, approval, contract negotiation, activation, regulation and tracking and reporting protocols.
•             Review new concepts and protocols in development and provide the principal investigator with recommendations regarding patient safety, protocol inconsistencies and requirements.
•             Participate on project teams to provide regulatory leadership and input. Provide recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the need and importance of regulatory requirements.
•             Communicate and educate members of the regulatory team and other support staff as required on changes due to new or related regulatory requirements.

 

Maintenance of Integrity of Clinical Trials    •       Independently prepares protocol submissions that comply with regulatory and institutional requirements. Works with study sponsors and/or Clinical Research Organizations (CROs)) to facilitate the approval of regulatory documents that conform to both MD Anderson and Sponsor requirements. 
•             Facilitate cohesiveness and improve regulatory compliance consistency and integration of departmental goals.
•             Coordinates activities associated with site start-up and overall regulatory management of the studies.
•             Develops and maintains a processing and tracking systems for protocol related paperwork.
•             Reviews protocols, amendments, and ancillary documents for discrepancies and/or lack of clarity. Works with PI and/or Sponsor to resolve these.  
•             Prepares and submits various reports to sponsors, investigators, regulatory authorities, and Admin Dir, Protocol Research and any others deemed necessary.
•             Ensures compliance with Good Clinical Research Practice standards.
•             Attends in-services, departmental meetings, mandatory training, and/or other events to remain abreast of new policies/procedures affecting the conduct of protocols.
•             Disseminates pertinent information to other team members. Participates in the development of departmental policies and procedures related to protocol research.
•             Assists in the development of in-service educational events for GIMO team members.
•             Maintains knowledge of clinical trials process

Other duties as assigned

 

COMPETENCIES



Strategic Thinking - Define strategic goals and issues clearly; apply broad knowledge and experience when addressing strategic issues; foresee obstacles and opportunities relating to change or improvement.

 

Service Orientation
Provide service to our customers, including patients, patient caregivers, referring physicians and each other, in a reliable, responsive, safe, friendly and courteous manner.

• Promotes inclusiveness and collegiality by demonstrating respect and professionalism to others at all times

• Models safe, ethical behavior, mitigating risk to the institution through sound business practices, and adherence to MD Anderson’s Standards of Conduct, institutional policies and procedures

Meets time and attendance expectations and responds to requests in a timely manner, communicating expectations for procedures, service arrival, or project deliverables to patients and coworkers

• Admits when wrong, apologize and take steps to resolve a situation to help to patients and coworkers before being asked

 

 

 

REQUIREMENTS

 

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

 

Preferred Education: None

 

Certification: None

 

Preferred Certification: None

 

Experience: 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 or completed years of college on a one to one basis. 
 


Preferred Experience: Clinical studies experience at MD Anderson.
 

 

Onsite Presence: Is Required

 

WORKING CONDITIONS

 

Frequency

Deadlines
Sedentary Environment

--
Constant 67-100%

 

PHYSICAL DEMANDS

 

Frequency

Weight

Keyboarding
Kneeling
Lifting
Pushing/Pulling
Reaching
Sitting
Standing

Constant 67-100%
Occasionally 11-33%
Occasionally 11-33%
Occasionally 11-33%
Occasionally 11-33%
Constant 67-100%
Occasionally 11-33%

--
--
5-10 lbs
5-10 lbs
--
--
--

 

COGNITIVE DEMANDS

Analytical Ability
Attention to detail
Interpersonal Skills
Comprehending
Following Instructions
Giving and Receiving Constructive Feedback
Memorizing/Remembering
Multitasking
Oral Communication
Organizing
Performing in a Leadership Role
Problem Solving
Reading Skills/Comprehension
Working Alone
Written Communication

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. 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

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