MD Anderson Cancer Center Senior Clinical Studies Coordinator | Pediatrics - Patient Care in Houston, Texas
The primary purpose of the Senior Clinical Studies Coordinator is to provide day-to-day management and oversight of protocol compliance, patient care, and issues related to the coordination of clinical trials. Additionally, effective operations of designated protocols include the development and resolution of issues in collaboration with the principal investigator. Trains, and mentors incoming and existing staff in study coordination to include training and guidance of policies and procedures that are related to the conduct of clinical trials. Assists with the writing and implementation of standard operating procedures, study start-up activities, and internal site initiation visits related to pediatric-patient care clinical research activities. Performs quality assurance reviews to monitor compliance and verify data accuracy. Assists with supervisory functions as assigned, including the review of informed consent documents.
The ideal candidate will have a Bachelor's degree and two years of recent experience as a Clinical Studies Coordinator at MD Anderson.
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 schedulers 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.
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.
Education: Bachelor's degree.
Preferred Education: Master's degree in Public Health or related scientific field.
Experience: 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
Requisition ID: 152769
Employment Status: Full-Time
Employee Status: Regular
FLSA: non-exempt, eligible for overtime, and is subject to the provisions of the Fair Labor Standards Act (FLSA)
Work Week: Day/Evening, Days
Fund Type: Soft
Work Location: Onsite
Pivotal Position: No
Minimum Salary: US Dollar (USD) 61,500
Midpoint Salary: US Dollar (USD) 77,000
Maximum Salary : US Dollar (USD) 92,500
Science Jobs: No