Clinical Studies Coordinator Opportunity Pediatrics - Patient Care
Ideal candidate must have a Bachelor's degree and three years' experience in an area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience. Prefer Clinical Research Coordinator (CCRC) and/or Clinical Research Professional (CCRP) certifications.
The primary purpose of the Coordinator, Clinical Studies is to provide day to day management and oversight of protocol compliance.
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, protocol responses. Collaborate with the multidisciplinary team as necessary to achieve the objectives of the trial.
* Collaborate with physicians, advanced practice providers, and 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 setting.
*Perform protocol specific duties under 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 include 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 and visits .
* Prepare continuing reviews and annual reports
* Conducts quality assurance data reviews to evaluate protocol compliance and data accuracy as assigned.
*Promotes 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.
*Prepares and maintains records of source documents for data verification.
Other duties as assigned
Education: Bachelor's degree.
Preferred Education: Master's Level Degree
Preferred Certification: Certified Clinical Research Coordinator (CCRC)
Certified Clinical Research Professional (CCRP)
Experience: Three years' experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience.
Preferred Experience: None
Onsite Presence: Is Required
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. [Register to View]
- Requisition ID: 150701
- 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: Days
- Fund Type: Soft
- Work Location: Hybrid Onsite/Remote
- Pivotal Position: No
- Minimum Salary: US Dollar (USD) 53,000
- Midpoint Salary: US Dollar (USD) 66,000
- Maximum Salary : US Dollar (USD) 79,000
- Science Jobs: No