Senior Coordinator, Clinical Studies

Senior Coordinator, Clinical Studies

Key Functions

Senior Level Study Management

• Performs all of the functions of a Clinical Research Program Coordinator, outlined below.
• Serves as a resource for departmental colleagues.
• Provides mentorship and training for new employees
• Will provide supervision and have oversight to the coordinator, of Clinical Research - responsible for time off requests, timekeeping, performance appraisals, coaching/counseling, rewards and recognition, continuing education and development.

Administrative Management of Clinical Trials

• Manages administrative/regulatory aspects of research trials by managing the scheduling follow up of patients.
• Dedicated to research patients and GI lab.
• Acts as a liaison with faculty,GIMO department staff and GI Center PSCs
• Ensures that all reviews are addressed to the satisfaction of the reviewers.
• Develops and maintains a processing and tracking systems for protocol scheduling and treatments
• Creates, updates, and maintains organizational files which include all pertinent correspondence and information regarding regulatory activities for GIMO clinical trials.
• Maintains an up-to-date status report of scheduling and any conflicts or changes related to studies
• Coordinate protocol and scheduling needs with GI PSCs in a timely manner, providing follow up as needed.
• Orders Tissue samples as needed
• Requires considerable exercise of independent judgment, initiative, and a basic knowledge of medical terminology, add-ons and administrative procedures.

Maintenance of Integrity of Clinical Trials

• Reviews EPIC for scheduling discrepancies and overbooks

• Facilitates scheduling across service lines to ensure patients receive timely testing
• Assists with strategic and long-range planning of departments' clinical trials program.
• Collaboratively works with all department clinical faculty to provide support for clinical trials goals. 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

Orients new faculty/support personnel on department's clinical trials research infrastructure and procedures

Laboratory Involvement

• Provides oversight for the submission and maintenance of laboratory-based protocols.
• Monitors the processes associated with treatment and scheduling with the Research Nurse and or PI to ensure the technical lab personnel and scientists are knowledgeable of their roles and responsibilities
• Submit and manage amendments, updates, and other documents associated with the protocol

MARGINAL OR PERIODIC FUNCTIONS:

• Other duties as assigned.
• This position will require a person who is motivated and willing to learn new skills.
• Represent department in a professional and appropriate manner within the institution, as well as externally.
• Must also be able to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds.
• Requires use of typewriter and computer via keyboard, and operating facsimile machine, calculator, printer, photocopy machine, etc. Requires the use of push-button, multiple line telephone set. Master new software by utilizing available resources (other department personnel, reference manual, taking classes, etc.
• Must be able to use all office equipment as noted above. Read and understand printed and written data in English.
• The performance for all expected outcomes is measured by observation by supervisor, reports from physicians and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress.

Bachelor's degree. 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. 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