Clinical Research Coordinator, RN

START Center for Cancer Research•Kentwood, MI

24d•Onsite

About The Position

The START Center for Cancer Research is seeking a Clinical Research Coordinator, RN to support daily activities of early-phase oncology clinical trials under the guidance of senior research staff. The coordinator ensures trials are conducted accurately and on time in accordance with study protocols, regulatory requirements, Good Clinical Practice (GCP), and patient-safety standards. The role includes 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 accurate, current information to team members involved in conducting the protocols. The schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m. The position is located at START Midwest, 5800 Foremost Dr SE, Grand Rapids, Michigan 49546. The START Center for Cancer Research is an early-phase oncology clinical research site network with eight clinical trial sites. Its sites have conducted more than a thousand early-phase clinical trials, including trials for 43 therapies approved by the FDA.

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 questions, concerns, and protocol status.
Monitor the day-to-day conduct of assigned studies according to 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 determinations.
Facilitate the informed consent process and ensure consent is appropriately completed.
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 trial patients when necessary.
Educate patients about clinical-trial participation, chemotherapy, biotherapy, investigational-agent administration, and potential side effects.