Clinical Research Coordinator Bleeding Disorders

Job Title & Specialty Area: Clinical Research Coordinator

Department: Hematology

Location: Dallas

Shift: Day

Job Type: Hybrid

Bleeding Disorders (Hemostasis and Thrombosis) Clinical Research Coordinator (CRC)

• CRC will work on a variety of study types including investigator initiated, consortium and industry sponsored trials

• Studies involve patients with bleeding disorders (hemophilia, von

Willebrand disease, other factor deficiencies) as well as patients with thrombosis (clotting, deep vein thrombosis, pulmonary embolism)

• Studies are therapeutic (treatment related) trials, observational (questionnaires, biology specimen and/or other procedures such as MRI, echos, exercise testing) and or registry type (database- lots of data entry) studies

• CRC will meet/interact with patients and parents in the outpatient clinic as well as inpatient units to discuss participation in studies. CRC will need to call patients on the phone/video call for consenting and follow up conversations.

• Small group of physicians (3) all 3 involved in research and clinical care.

• CRC should be open to flexible working hours (position is primarily Mon-Friday, day shift, but occasional weekend time may be required)

• Position involves local travel (around Dallas/Plano) for study related activities

• Preferred Skill set:

o Research coordinating experience preferred

o Knowledge of investigator-initiated studies (takes extra effort to coordinate logistics, create case report forms, figure out the flow of a study)

o Working knowledge of REDCap, and if knows how to build REDCap, this would be helpful

o Must be comfortable using multiple computer software programs, platforms, technologies (all data is collected in electronic formats)

o Experience talking with pediatric patients and their parents about research preferred

o Takes initiative to create better processes, initiative to see what needs to get done and do it

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. 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:

• 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.

• Specific only for positions in Trauma Services: Coordinate with Trauma Registry in obtaining trauma registry reports as needed and approved for research studies. Collect both retrospective and prospective data as required and approved for research studies. Create and maintain study specific databases and data collection tools, and educate others in data collection. Serve as a resource to others conducting trauma/emergency services research at Children's.

How You'll Be Successful:

WORK EXPERIENCE

• At least 1 year related experience required

EDUCATION

• Four-year Bachelor's degree or equivalent experience required

• Graduate or professional work or advanced degree; or equivalent experience preferred

LICENSES AND CERTIFICATIONS

• CCRP/CCRC certification through SoCRA / ACRP preferred

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.