Clinical Research Program Coordinator - Pediatrics Patient Care

JOB SPECIFIC COMPETENCIES

Administrative Management of Clinical Trials
Manage administrative/regulatory aspects of research trials for federal and pharmaceutical funded protocols, through all components of a study. Works with PI's, sponsors, Clinical Research Organizations (CRO) and team members to prepare and submit regulatory documents, respond to protocol reviewer's comments. Coordinate with sponsor representative to assure consistency and maintain standard record documentation. Coordinate activities associated with site start-up and overall regulatory trial management.

Coordination with Sponsors
Act as a Pediatrics' primary liaison with legal services and sponsors for industry sponsored projects. Coordinate activities associated with site start up and overall regulatory trial management. Assure the PI and research team are current on regulatory requirements

System Development
Develop and maintain a processing and tracking system for all protocol related paperwork. Collect and develop criteria information for protocol submission. Creates and maintains organizational files which include all pertinent correspondence and information regarding pre-award activities for pediatric clinical trials. Maintains an up-to-date status report and creates summary reports as requested for supervisor, PI, and/or management staff.

Audit and Quality Monitoring
Prepares and coordinates audit/monitor visits for protocol compliance and data quality review. Generate reports as requested. Assure accurate documentation.

Other duties as assigned

COMPETENCIES

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

Influence Others - Present a compelling case for proposals and ideas; advocate for support and commitment from others; mobilize others to take action for benefit of the institution.

Oral Communication - Express ideas clearly and concisely in groups and one-to-one conversations; create an environment with open channels of communication.

Team with Others - Initiate, develop, and manage relationships and networks; encourage collaboration and input from all team members; value the contributions of all team members; balance individual and team goals.

Written Communication - Convey information clearly and concisely through both formal and informal documents; adapt writing style to fit the audience.

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.

REQUIREMENTS

Required Education: Bachelor's degree
Preferred Education: Master's Level Degree

Required Experience: 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.

Preferred Certification: SOCRA, Certified Clinical Research Professional

Onsite Presence: Is Not Required.

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