Trial Master File Jobs in Dallas, TX (NOW HIRING)

At Iterative Health, we're transforming clinical research by making trials more accessible, efficient, and patient-centered. As a Infusion Registered Nurse, you'll play a role in delivering safe, protocol-driven clinical care while supporting the successful execution of research studies. Working closely with Principal Investigators, Clinical Research Coordinators, and site leadership, you'll ensure study participants receive high-quality care while maintaining the integrity of clinical trial data and regulatory compliance.

• Administer investigational products, infusions, injections, and other protocol-required treatments in accordance with study protocols, physician orders, and Good Clinical Practice (GCP).
• Perform protocol-specific clinical procedures including vital signs, specimen collection, ECGs, medication administration, and participant assessments.
• Monitor participants before, during, and after study procedures, identifying aComplete all training and documentation required during study startup for timely site activation nd responding appropriately to adverse events or changes in clinical status.
• Collaborate with Principal Investigators, Clinical Research Coordinators, and study teams to ensure protocol compliance and participant safety.

• Educate research participants on study procedures, treatment expectations, and follow-up requirements.
• Obtain and document participant assessments while maintaining compassionate, patient-centered care.
• Complete all training and documentation required during study startup for timely site activation 
• Foster positive participant relationships through clear communication and exceptional clinical support.
• Protect the rights, safety, and welfare of all research participants in accordance with federal regulations and ethical research standards.

• Complete accurate and timely source documentation, nursing notes, infusion records, case report forms, and other required study documentation.
• Maintain investigational product accountability and documentation in accordance with sponsor protocols, FDA regulations, and Iterative Health policies.
• Support regulatory readiness by maintaining organized study files and documentation required for sponsor monitoring visits and audits.
• Ensure secure handling of Protected Health Information (PHI) and comply with HIPAA and organizational privacy policies.

• Maintain adequate inventory of clinical and study supplies while supporting proper storage and handling of investigational products.
• Communicate effectively with sponsors, study participants, investigators, and internal research teams throughout the study lifecycle.
• Assist with study start-up, participant visits, monitoring visits, and study closeout activities as needed.
• Support continuous process improvement initiatives and perform additional responsibilities as assigned.

• Perform job related duties as requested 

• Associate or Bachelor's Nursing Degree
• Active, unrestricted Registered Nurse (RN) state license 
• Minimum of 3 years of infusion RN experience 
• 1-2 years of clinical research experience strongly preferred; equivalent experience in a clinical nursing environment will also be considered.
• Working knowledge of Good Clinical Practice (GCP), informed consent, and human subject protection principles.
• Excellent verbal and written communication skills, with the ability to educate research participants and collaborate effectively across multidisciplinary teams.
• Strong organizational, time management, and critical thinking skills with the ability to prioritize multiple studies and meet competing deadlines.
• Ability to read, interpret, and apply research protocols, sponsor requirements, clinic policies, and regulatory guidelines.
• Proficiency with Microsoft Office applications and the ability to quickly learn clinical research technologies, including Clinical Trial Management Systems (CTMS) and Electronic Medical Record (EMR) platforms.
• Ability to work independently while contributing effectively within a collaborative, fast-paced research environment.

• Prior experience in gastroenterology (GI), hepatology, infusion services, or other specialty clinical research settings.
• Experience administering investigational products, biologics, or protocol-driven infusions.
• Familiarity with FDA regulations, ICH-GCP guidelines, and clinical trial documentation standards.
• Experience using CTMS, Electronic Data Capture (EDC), electronic Trial Master File (eTMF), or similar clinical research systems.
• ACRP or SOCRA certification (CCRC or CCRP), or a commitment to obtaining certification within the first year of employment.