Clinical Research Coordinator, RN

START Center for Cancer Research•Pittsburgh, PA

26d•Onsite

About The Position

The Clinical Research Coordinator, RN supports the daily activities of early-phase oncology clinical trials under the guidance of senior research staff. The role ensures accurate and timely trial conduct in accordance with protocols, regulatory requirements, Good Clinical Practice (GCP), and patient-safety standards. It involves direct patient interaction, data collection, and responsibility for multiple assigned protocols, including planning and coordinating patient participation and implementing and completing protocol-specific requirements. The coordinator provides accurate, current information to team members involved in carrying out those requirements. The position is based at START – Pittsburgh, 320 East North Avenue, Pittsburgh, PA 15212, with a Monday-Friday schedule from 8:00 a.m. to 5:00 p.m. The work takes place in a fast-paced, changing healthcare environment and involves working closely with physicians and ancillary personnel caring for oncology and hematology patients. Approximately 80% of the time is spent sitting. START is an oncology clinical research network dedicated to early-phase trials. The organization describes its mission as providing patients access to novel cancer treatments and advancing therapies from trials to treatment.

Requirements

Associate’s degree in Nursing.
RN license in the state where practicing.
2 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 others regarding 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 completed appropriately.
Prepare and manage source documents according to standard operating procedures.
Recognize 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 with the data coordinator.
Provide documentation for deviations related to protocols or SOPs.
Ensure team members understand and adhere to assigned protocols.
Perform telephone triage assessments of patients on trial when necessary.
Educate patients about clinical-trial participation, chemotherapy, biotherapy, investigational-agent administration, and potential side effects.