Clinical Research Coordinator, RN
About The Position
The Clinical Research Coordinator, RN works under the guidance of senior research staff to support daily activities of early-phase oncology clinical trials. The coordinator ensures accurate and timely trial conduct in accordance with protocols, regulatory requirements, Good Clinical Practice (GCP), and patient-safety standards. The role involves direct patient interaction, data collection, and oversight of multiple assigned protocols, including planning and coordinating patient participation and implementing and completing protocol-specific requirements. The coordinator provides current, accurate information to all team members involved in carrying out those requirements.
Requirements
- Associate’s degree in Nursing.
- RN license in the state where practicing.
- Two years of clinical research experience.
- Basic understanding of oncology clinical trials, particularly Phase 1 studies.
- Strong attention to detail and accuracy in data collection and documentation.
- Ability to manage multiple tasks and meet deadlines in a fast-paced environment.
- Excellent organizational and time-management skills.
- Strong written and verbal communication skills.
- Ability to interact professionally with patients, study staff, and external stakeholders.
- Working knowledge of GCP and regulatory requirements.
- Proficiency in Microsoft Office Suite and clinical trial management software.
Nice To Haves
- Bachelor’s degree in Nursing.
- Experience working in an oncology setting.
Responsibilities
- Communicate regularly with study sponsors, CROs, staff, and other stakeholders about protocol questions, concerns, and status.
- Monitor the day-to-day conduct of assigned studies in accordance with protocol requirements, Standard Operating Procedures, and Good Clinical Practice.
- Create or review forms for assigned trials to ensure protocol compliance.
- Maintain study files using standardized document labeling and filing procedures.
- Implement initial protocols and amendments, and train staff involved in patient treatment and management.
- Maintain an up-to-date contact list.
- Assist with patient screening and eligibility determination.
- Facilitate the informed consent process and ensure consent is appropriately completed.
- Prepare and manage source documents according to standard operating procedures.
- Identify protocol deviations and work with leadership and staff on corrective actions to prevent deviations.
- Assist the data coordinator team with case report form completion and query resolution.
- Work with the Principal Investigator to complete and submit Serious Adverse Event reports.
- Perform protocol-specific closeout activities in conjunction with the data coordinator.
- Document all deviations, whether related to a protocol or an SOP.
- Ensure team members understand and adhere to assigned protocols.
- Perform telephone triage assessments of patients on trial when necessary.
- Educate patients about trial participation, chemotherapy, biotherapy, investigational agent administration, and potential side effects.
Benefits
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k) plan with employer matching.
- Life insurance.
- Disability insurance.
- Health savings accounts.
- Flexible spending accounts.
- Paid time off.
- Flexible schedule.
- Remote work choices.
- Collaborative, creative environment with opportunities to learn and grow.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
