Clinical Research Coordinator (Hematology CRC)

Location: Dallas and Plano campuses; remote work permitted some days based on business needs

About the Role

The Clinical Research Coordinator coordinates device and drug treatment research trials, as well as observational studies conducted at Children's Medical Center. Responsibilities include study set-up, implementation, fiscal monitoring, and data collection/entry. Serves as the primary Children's employee managing all aspects of assigned research projects, ensuring compliance with Children's policies, state, and federal regulations.

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 and perform scheduling of procedures and treatments; serve as an educational resource for participants regarding study requirements.
• Review 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 ongoing data.
• Communicate with pharmacy to ensure investigational drug is ordered per protocol when needed.
• Clinically licensed coordinators may administer study-related medications.
• Open and maintain institutional approval for research studies, including IRB submissions (consent forms, HIPAA forms, project summaries), amendments, annual reviews, and adverse event reporting.
• Consult with Children's Medical Center Research Department to establish coordinator timesheets, service orders, input research orders in EPIC, and ensure compliance with research billing laws and policies.
• Communicate with sponsors to keep all documents updated.
• Coordinate 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 sterile condition and distribute to local and national clinical and research laboratories.
• Assist in labeling and storing 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.

Requirements

• At least 1 year of related experience.
• Master's Degree (preferred) or Bachelor's Degree (required).

Benefits

• Employee portion of medical plan premiums 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.

Schedule

Full-time, Monday through Friday, 8:30 AM to 5:00 PM.