The primary purpose of the Senior Coordinator, Clinical Studies 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 an MD or PhD in a related field with prior experience in research, study coordination and clinical experience with patients.JOB-SPECIFIC COMPETENCIESClinical Trials Coordination:
Patient Coordination and Support
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.
Protocol and Documentation Management
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.
Regulatory Correspondence and Compliance
Coordination of regulatory correspondence on clinical research studies.
Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).
Complete forms and comply with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.
Clinical Trial Protocol Support
Direct support to clinical trial research protocols.
Review protocol documents including abstracts, text and informed consent for relevant information.
Register patients on research protocols by verifying eligibility/exclusion criteria and entering patients in CORE per protocol. Communicate necessary registration information to sponsoring drug company as directed by PI, and with the assistance of the research nurse.
Schedule patient tests; keep patients informed about test results and studies.
Assist in obtaining consent for studies.
Interdepartmental and External Coordination
Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies. If required for multi-center trials, maintain contact with other institutions in studies and coordinates all data pertaining to such studies.
Data Management and Reporting
Complete case report forms in a timely and accurate fashion.
Assist in the assessing for adverse events.
Follow patients while on study for safety monitoring. Adhere to institutional policies concerning safety and infection control.
Provide support for labor-intensive protocols as needed.
Monitor protocol compliance by assisting in coordination of protocol-specific lab, radiographic, and clinical evaluation of patients.
Specimen and Record Collection
Act as a lead in data collection by retrieving protocol information via computer and visual chart review and by communicating directly with outlying healthcare providers to schedule and procure testing and treatment records.
Obtain outside films, surgical, pathology and lab reports as needed per protocol and submitting specimens/films for reading.
Collect or facilitate the collection of specimens as outlined in assigned protocols upon request.
Develop and maintain database for tracking specimens with high level of accuracy.
Serve as an information source regarding status of samples collected from patients on given protocols for PI and sponsors.
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.
Retrieve protocol-related data as documented in the medical record and accurately enter it into a computerized database or on a handwritten case report form.
Generate OnCore/CORE and other applicable data reports, protocol summary reports, and user-generated data reports as requested.
Provide assistance upon request for the preparation of technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.
Additional projects, as assigned.
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.
To maintain a high level of professional expertise and credibility through educational programs, including on-site training and off-site conferences.
Attend department research meetings and conferences.
Attend approved off-site meetings and conferences.
Supplement education as needed through use of reference materials, lectures, etc.
Be punctual in arriving at all professional functions.
Inform appropriate staff and arrange coverage for necessary functions when absent.
Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
EDUCATIONRequired: Bachelor's degree.Preferred: Master's degree.EXPERIENCERequired: 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.htmlAdditional Information
Requisition ID: 171388
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 65,000
Midpoint Salary: US Dollar (USD) 81,000
Maximum Salary : US Dollar (USD) 97,000
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Hybrid Onsite/Remote
Pivotal Position: Yes
Referral Bonus Available?: No
Relocation Assistance Available?: Yes
Science Jobs: No
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