Senior Clinical Studies Coordinator - Epidemiology

The primary purpose of the position is to provide support in various prospective follow-up studies on the epidemiology and outcomes of colorectal and kidney cancers. The incumbent in this position will assume primary responsibility for administrative and research operations and will perform duties in accordance with good clinical and research practice. Requires considerable independent judgment, initiative, and decision-making related to patients/participants needs and study activities. In addition, responsible for the overall effective operation of designated protocols to include development, design and resolution of operations and budget issues in collaboration with the principal investigator or study sponsor. Trains other support staff in study coordination to include providing training and guidance with regard to the policies and procedures that are related to conduct of human studies; planning, designing and conducting complex professional and ancillary staff education sessions to ensure protocol compliance and dissemination of new information and policies. Coordinates study protocol submissions and prepare key study reports. Performs QA audits to monitor compliance and accuracy of data. Compiles study data for manuscript submission. Assists with supervisory functions, participates in the evaluation process.

Project Management- Administrative

• Collaborate with PI to prepare protocol.
• Collaborate with PI in providing reports for scientific publications and to sponsors.
• Collaborate with PI to plan the content and direction of project-related tasks and activities.
• Supervise staff including developing and implementing training plan, monitoring performance and staffing studies as needed.
• Monitor study budget and resources.
• Prepares and gives presentations.
• Assist with the recruitment and hiring of new staff.
• Manage personal issues, including staff supervision, training and resolve workflow issues.
• Complete performance evaluations.
• Prepare reports and records for accountability and fidelity purposes.
• Develop and defines recruitment strategies for studies.
• Monitor and request advertisements as needed to maintain study recruitment goals.
• Recruit and screen participants for eligibility as well as register, schedule, and monitor their study participation and attendance.

Project Management- Data Collection

• Prepare standard operating procedures (SOPs) for study operations.
• Develop and maintain databases for collection of research data.
• Develop and design data collection instruments and questionnaire testing procedures.
• Collect specimens as outlined in assigned protocols.
• Coordinates the acquisition of research blood or tissue specimens correctly and in a timely fashion and transport to appropriate locations, as specified by protocols.
• Follow up on lab/translational data collection, processing, and compilation.
• Maintain the ordering of study supplies needed to perform study related tasks.
• Order, dispense to research staff, review and reconcile compensation given to participants.
• Deliver assessments and maintain appropriate documentation.

Project Management- Reporting/Regulatory

• Facilitate weekly strategy meetings aimed at identifying needed protocol and procedural changes, coordinating the ongoing implementation of the research protocol, and defining recruitment strategies.
• Maintain liaison and interface with investigative team, clinical/medical personnel, and participants through oral and written communication.
• Complete protocol submissions and resubmissions, create and maintain source documents, monitor data collection to ensure compliance with federal, state and institutional guidelines.
• Maintain and adhere to regulatory documents and policies.
• Report adverse events and protocol deviations per institution procedures.
• Prepare and complete study close out procedures in compliance with institution and sponsor procedures.

COMPETENCIES

Analytical Thinking - Gather relevant information systematically; break down problems into simple components; make sound decisions.
Innovative Thinking - Approach problems with curiosity and open-mindedness; offer new ideas, solutions and/or options.
Develop Oneself - Pursue learning and self-development; actively seek feedback; transfer learning into next steps; set high standards of performance; drive for results and achievement.

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

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

Patient Care - Employee demonstrates population-based competencies (age-specific, diversity) that cross the continuum of care; Employee functions within their professional scope.
Professionalism - Employee demonstrates commitment to collaborative professional relationships with physicians and all members of the heath care team.
Self-Confidence - Recognize own knowledge, skills, and abilities; respond to challenging situations with confidence; understand limits in self.
Practice-Based Learning and Improvement - Employee participates in on-going learning and demonstrates application of it in his/her role.

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.

EDUCATION:
Required: Bachelor's degree.

Preferred: Master's degree Public Health or related scientific field..

EXPERIENCE:
Required: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. 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.

Preferred: Spanish speaking, Strong writing skills

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