Remote Clinical Research Protocol Writer Jobs in Texas

Job Title & Specialty Area: Clinical Research Coordinator
Department: Hematology Oncology Research
Location: Both Dallas and Plano campuses, remote work can be permitted some days provided business needs are met
Shift: Full-time Monday through Friday 8:30a to 5:00p
Job Type: Onsite
Why Children's Health?
At Children's Health, our mission is to Make Life Better for Children, and we recognize that their health plays a crucial role in achieving this goal.
Through our cutting-edge treatments and affiliation with UT Southwestern, we strive to deliver an extraordinary patient and family experience, ensuring that every moment, big or small, contributes to their overall well-being.
Our dedication to promoting children's health extends beyond our organization and encompasses the broader community. Together, we can make a significant difference in the lives of children and contribute to a brighter and healthier future for all.
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. 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:
* 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. *This CRC will work on a variety of study types including investigator initiated, consortium and industry sponsored trials. *Studies involve patients with bleeding disorders (hemophilia, Vo Willebrand disease, other factor deficiencies) as well as patients with thrombosis (clotting, deep vein thrombosis, pulmonary embolism). *This CRC will also coordinate studies in our sickle cell disease clinic working closely with faculty on investigator-initiated protocols.

• Work will include writing manual of operations and developing case report forms. Knowledge of REDCap database is essential. Being able to develop REDCap surveys and case report forms is desired.
• CRC will screen for eligible patient, consent and complete data entry for enrolled participants as well as handle and process biological specimens.
• This CRC will administer a variety of Patient Related Outcome questionnaires to participants, score and enter the data.

How You'll Be Successful:
WORK EXPERIENCE
*At least 1-year related experience Required
EDUCATION
* Master's Degree Preferred
* Bachelor's Degree Required
A Place Where You Belong
We put our people first. We welcome, value, and respect the beliefs, identities and experiences of our patients and colleagues. We are committed to delivering culturally effective care, creating meaningful partnerships in the communities we serve, and equipping and developing our team members to make Children's Health a place where everyone can contribute.
Holistic Benefits - How We'll Care for You:
• Employee portion of medical plan premiums are covered after 3 years.
• 4%-10% employee savings plan match based on tenure
• Paid Parental Leave (up to 12 weeks)
• Caregiver Leave
• Adoption and surrogacy reimbursement
As an equal opportunity employer, Children's Health does not discriminate against employees or applicants because of race, color, religion, sex, gender identity and expression, sexual orientation, age, national origin, veteran or military status, disability, or genetic information or any other Federal or State legally protected status or class. This applies to all aspects of the employer-employee relationship including but not limited to recruitment, hiring, promotion, transfer pay, training, discipline, workforce adjustments, termination, employee benefits, and any other employment-related activity.