Clinical Research Nurse

Clinical Research Nurse Coordinator

The Clinical Research Nurse Coordinator oversees and coordinates the clinical operations of assigned oncology clinical trials, ensuring compliant study conduct in alignment with local, federal, and state regulations and institutional policies. This role serves as a key liaison among principal investigators, sub-investigators, clinical research nurses, regulatory specialists, and study patients, supporting trial feasibility, regulatory submissions, patient recruitment and education, and accurate documentation of all study-related activities.

Responsibilities

• Act as a primary liaison between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists on all regulatory issues and protocol changes.
• Collaborate with principal investigators, clinical research coordinators, and the clinical team to review studies for feasibility and evaluate potential competition with other protocols prior to submission.
• Assist principal investigators in preparing proposed clinical trials by reviewing trial protocols, contacting departments that will provide study resources, and ensuring appropriate departments are notified and receive trial documentation, including scientific merit and accrual potential.
• Ensure all protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the appropriate Institutional Review Board (IRB) of record in a timely manner.
• Review studies with principal investigators and/or clinical research coordinators to develop budgets that outline standard-of-care and research costs, and finalize budget drafts with the budget coordinator.
• Recruit and evaluate potential study patients and work with clinical research coordinators to schedule required appointments and interviews.
• Identify the needs of the patient population served and tailor care to those needs, including age, culture, and sensory impairments, communicating with patients, parents, and caregivers at an appropriate developmental, educational, and literacy level.
• Review medical records for potential study patients and ensure records include complete documentation of laboratory test results, procedures, and progress, following protocol sponsor guidelines.
• Instruct potential study patients, designated caregivers, physicians, nurse clinicians, and ancillary staff on aspects of patient care, available trials, treatments, and possible side effects.
• Assist investigators with the informed consent process, ensuring study patients understand clinical trials and obtaining written informed consent.
• Educate study patients regarding informed consent procedures and HIPAA authorization requirements.
• Document study patients' medical histories, including past medical and surgical treatments, significant medical conditions, and medication histories, in accordance with protocol guidelines.
• Perform nursing assessments and monitor study patients' progress during clinical trials, tracking responses using toxicity flow sheets, medication flow sheets, and nursing progress notes.
• Maintain accurate, complete, and up-to-date records on each patient participating in clinical trial protocols across all applicable systems, including electronic medical records, clinical trial management systems, departmental databases, and protocol-specific databases.
• Evaluate and develop study patient education materials and provide instructions to patients and caregivers on drug administration and other medical information, including creating study-specific calendars.
• Plan appropriate patient care under the direction of a physician or advanced practice nurse to support clinical trial requirements.
• Notify principal investigators of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects.
• Report all serious adverse events to study sponsors and IRBs of record according to established timelines and regulatory requirements.
• Coordinate research activities, including scheduling laboratory tests, radiology exams, and other medical procedures required by the protocol.
• Perform and/or oversee clinical duties such as EKGs and processing and shipping blood serum and urine samples, and communicate results to principal investigators and advanced practice nurses.
• Review and process safety reports (including IND safety reports and other sponsor safety communications) together with the principal investigator, following institutional policies and procedures.
• Act as the principal investigator's representative when appropriate, including communicating with sponsors and their representatives, the IRB, and other medical personnel.
• Ensure that study-related clinical activities are billed appropriately and reconcile drug study account records with research finance personnel.
• Prepare for and assist with sponsor monitor site visits, ensuring all supporting documentation is adequate and available, meeting with monitors during visits, and resolving issues identified.
• Develop case report forms and/or databases for physician-initiated studies as needed to support data collection and reporting.
• Assist principal investigators in preparing study results for publication and work with analysts to address data queries and evaluate the significance of collected data.
• Provide education to all departments and clinical areas where studies are performed to support understanding of protocols and study requirements.
• Oversee clinical operations and evaluate patient care within assigned oncology clinical trials while supporting principal investigators in day-to-day research activities.

Essential Skills

• Active Registered Nurse (RN) license with clinical nursing experience.
• Bachelor of Science in Nursing (BSN) required; advanced master's degree in nursing programs may satisfy the BSN requirement (for example, Associates to MSN).
• Minimum of 3 years of clinical nursing experience, or 1 year of clinical nursing experience combined with at least 2 years of clinical research experience.
• Demonstrated experience as a clinical research nurse or clinical research coordinator in an oncology setting.
• Ability to coordinate and oversee clinical operations for multiple concurrent clinical trials.
• Strong knowledge of clinical research processes, including protocol review, feasibility assessment, and study start-up activities.
• Proficiency in regulatory processes related to clinical trials, including IRB submissions, continuing reviews, protocol amendments, and serious adverse event reporting.
• Skill in recruiting, screening, and evaluating potential study patients for eligibility.
• Competence in performing nursing assessments and monitoring patients during clinical trials.
• Ability to maintain accurate, complete, and up-to-date patient and study records across electronic medical records, clinical trial management systems, and study databases.
• Strong communication skills for educating patients, caregivers, physicians, nurses, and ancillary staff about clinical trials, treatments, and side effects.
• Ability to tailor communication and care to diverse patient populations, considering age, culture, and sensory or literacy needs.
• Experience with developing and managing study budgets in collaboration with investigators and budget coordinators.
• Ability to coordinate laboratory, radiology, and other medical testing required by clinical trial protocols.
• Competence in handling clinical duties such as EKGs and processing and shipping biological specimens.
• Knowledge of HIPAA regulations and informed consent procedures in clinical research.
• Ability to identify, document, and report adverse events and serious adverse events in accordance with sponsor and IRB requirements.
• Strong organizational skills to manage multiple studies, deadlines, and monitoring visits.
• Ability to work under the general supervision of a principal investigator while independently carrying out day-to-day research responsibilities.

Additional Skills & Qualifications

• Oncology nursing experience and familiarity with oncology clinical trials.
• Oncology Certified Nurse (OCN) credential or eligibility is highly beneficial.
• Experience as a Clinical Research Coordinator or Clinical Research Nurse in complex, multi-protocol environments.
• Comfort working with principal investigators, sub-investigators, regulatory specialists, and research finance teams.
• Experience developing case report forms and study-specific databases for physician-initiated studies.
• Background in supporting publication efforts, including collaborating with analysts on data queries and interpretation.
• Ability to educate and train staff across departments and clinical areas where studies are performed.
• Strong teamwork skills, with the ability to collaborate within a multidisciplinary research team.
• Experience managing a workload of several concurrent clinical trials and interacting with multiple clinicians.
• Detail-oriented approach to documentation, billing reconciliation, and preparation for sponsor monitoring visits.

Work Environment

This position operates within a collaborative oncology clinical research environment focused on helping patients live better, healthier lives while supporting team members' success. The Clinical Research Coordinator works under the general supervision of the principal investigator responsible for assigned clinical trial(s) and follows all relevant local, federal, and state regulatory requirements, as well as institutional policies and Standard Operating Procedures. The team currently includes clinical research nurses, clinical research coordinators, and a senior data coordinator, with plans for growth to support an expanding portfolio of studies. The group manages more than twenty open clinical trials with additional studies in the pipeline and works closely with dozens of clinicians, with each coordinator or nurse typically handling four to five trials. The environment emphasizes connection, collaboration, and mutual support, with competitive benefits and a culture of showing up for both colleagues and the broader community. Work involves frequent interaction with electronic medical records, clinical trial management systems, departmental and