Address
Form of workThe Children's Cancer Hospital has been recognized in the U.S. News and World Report's annual list for the Best Hospitals for Pediatric Cancer Care. The ranking highlights the Children's Cancer Hospital's commitment to family-focused care, to providing access to novel clinical trials with potential to advance the field, to supportive care programs specifically designed for children, adolescents and young adults, and to advocating for the needs of this population.
The ideal candidate will have a Bachelors or advanced degree in Health Science, and at least five years of qualifying experience. Previous experience in clinical research is highly preferred.
JOB-SPECIFIC COMPETENCIES
Coordination of Clinical Trials
- Coordinate, evaluate, and follow patient progress while on studies maintaining knowledge of adverse events, protocol-related labs and research tests, and protocol responses. Collaborate with the multidisciplinary team as necessary to achieve the objectives of the trial.
- Collaborate with physicians, advanced practice providers, research nurses, and data managers to assure appropriate documentation of Patient Care and obtain the necessary information required by the protocol.
- Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.
- Perform protocol-specific duties under the direct supervision of protocol PI, research nurses manager/supervisor as needed or appropriate.
- Obtain informed consent for non-treatment studies and assist in obtaining informed consent for treatment studies by discussing the study requirements and answering any study-specific questions for the patient and family.
- Screen study patients for and report adverse events as required per the trial sponsor.
- Ensure that patients are scheduled for research-required tests and appointments by reviewing electronic health records and coordinating with schedules as needed.
- Complete the clinical content template for new submission of protocols or protocol amendments. That includes changes to the treatment plan including required tests.
- Creates and maintains delegation of authority log, as needed.
- Creates and maintains study-specific training logs, as needed.
- Ensures that data and regulatory documents are complete for audits and monitoring per standard operating procedures visits.
- Prepare continuing reviews and annual reports.
- Conducts quality assurance data reviews to evaluate protocol compliance and data accuracy as assigned.
Data Coordination and Quality Assurance
- Provide guidance and instruction to research support staff as needed to promote protocol compliance in accordance with federal and institutional standards.
- Communicates with clinical staff to ensure protocol patient safety and protocol compliance.
- Prepares data and participates in data review meetings as required by the department.
- Enters data and maintains management reports on the databases for various research purposes.
Education/ Training/ Mentoring
- Assist in developing an onboarding training manual to standardize the onboarding process for new research staff.
- Develops a training plan for incoming Clinical Studies Coordinators and research data coordinators.
- Provides updates to research staff regarding updates to or new institutional policies as appropriate.
- In collaboration with supervisor/ manager, implement a mentoring plan for incoming staff, as directed.
Supervisory
- Provides supervisory back-up as directed by supervisor/ manager.
- Provides performance evaluation feedback for staff members as requested.
Other duties as assigned
- Requires flexibility in work schedule due to operational requirements.
- Attend meetings/work responsibilities outside of the set schedule.
REQUIREMENTS
Education: Bachelor's degree.
Preferred Education: Bachelor's or Master's Level Degree or Ph.D. in Health Sciences.
Experience: Five years of experience in the area of research study or direct Patient Care obtained from nursing, data gathering, or related field. May substitute the required education degree with additional years of equivalent experience on a one-to-one basis. With the preferred degree, three years of the required experience.
Preferred Certification: Certified Clinical Research Coordinator (CCRC) or
Certified Clinical Research Professional (CCRP)
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
Additional Information
- Requisition ID: 157424
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Day/Evening, Days
- Minimum Salary: US Dollar (USD) 61,500
- Midpoint Salary: US Dollar (USD) 77,000
- Maximum Salary : US Dollar (USD) 92,500
- FLSA: non-exempt and eligible for overtime pay
- Fund Type: Soft
- Work Location: Onsite
- Pivotal Position: No
- Referral Bonus Available?: No
- Relocation Assistance Available?: No
- Science Jobs: Yes
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