- Evaluate patients for inclusion and exclusion criteria on multiple protocols. Consent and enroll subjects on trials as appropriate. Be familiar with treatment and visit schedules for assigned studies. Coordinate/perform scheduling of procedures and treatments and serve as an educational resource for participants regarding study requirements. Be proficient at reviewing medical records to assess patient's disease status, treatment course, and adverse events. Complete case report forms and submit to sponsor according to deadlines. Participate in long-term follow-up efforts on research participants and submit on-going data. Communicate with pharmacy to ensure investigational drug is ordered per protocol when needed. Clinically licensed coordinators may be responsible for administering study related medications.
- Open and maintain institutional approval for research studies including but not limited to initial Institutional Review Board submissions (creating consent forms, HIPAA forms, project summaries), new research questionnaires, amendments, annual reviews and adverse event reporting. Consult with Children's Medical Center Research Department to establish coordinator timesheets and service orders, input research orders in EPIC, and provide ongoing assistance with research billing to ensure compliance with applicable laws and institutional policies. Communicate with sponsor to keep all documents updated. Communicate with physicians and clinical staff regarding patient research participation.
- Coordinate sample procurement according to protocol and disease. Maintain samples of fluids and/or tissue in a sterile condition and promptly distribute to local and national clinical and research laboratories. Assist in labeling and storing of blood, urine and other specimens for analysis. Collect, correlate and file patient records and laboratory data for analysis. Receive reports and facilitate Principal Investigator review of results. Package and ship samples according to local and federal IATA guidelines. Reconcile shipment billing.
- At least 1 year related experience required
- Four-year Bachelor's degree or equivalent experience required
- Graduate or professional work or advanced degree; or equivalent experience preferred
- CCRP/CCRC certification through SoCRA / ACRP preferred
- Registered Nurse license preferred
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Clinical Research Coordinator Bone Marrow Transplant - Dallas, United States - Children's Health
Description
This is a hybrid position (remote and onsite in Dallas) supporting research in Hematology and OncologyABOUT THE JOB:
Summary:
The Clinical Research Coordinator may coordinate device and drug treatment research trials, as well as observational studies conducted at Children's Medical Center, including but not limited to study set-up, implementation, fiscal monitoring, and data collection/entry.
In the Trauma Services Department, may coordinate trauma and emergency services studies, including literature reviews,study development, and assist with data analysis.
Usually serves as the Children's employee managing the coordination of all aspects of the assigned research project(s) at Children's in support of the Principal Investigator and ensuring compliance with all Children's policies, state and federal regulations that govern clinical research.
Responsibilities:
Other information:
WORK EXPERIENCE
EDUCATION
LICENSES AND CERTIFICATIONS
Children's Health values the role each member of our team plays in helping us make life better for children. We employ more than 7,500 people and provide rewarding career opportunities that help them reach their highest potential.
We also hold Magnet recognition from the American Nurses Credentialing Center for nursing excellence, we serve as the primary pediatric teaching facility for the University of Texas Southwestern Medical Center, and we are widely recognized for delivering high quality care.
Children's Health has also been named one of the 150 Top Places to Work in Healthcare by Becker's Healthcare for nine consecutive years.
Benefits
Children's Health offers competitive pay, a comprehensive benefits program and opportunities for learning and career development.
We promote a diverse and inclusive workplace, and our team members have a voice in their work through surveys and town halls.
We invite you to learn more about Children's Health.
