Clinical Research Nurse
Cancer Treatment Centers of America® (CTCA®) takes a unique and integrative approach to cancer care. Our patient-centered care model is founded on a commitment to personalized medicine, tailoring a combination of treatments to the needs of each individual patient. At the same time, we support patients’ quality of life by offering therapies designed to help them manage the side effects of treatment, addressing their physical, spiritual and emotional needs, so they are better able to stay on their treatment regimens and get back to life. At the core of our whole-person approach is what we call the Mother Standard® of care, so named because it requires that we treat our patients, and one another, like we would want our loved ones to be treated. This innovative approach has earned our hospitals a Best Place to Work distinction and numerous accreditations. Each of us has a stake in the successful outcomes of every patient we treat. Job Description:
Cancer care is all we do
Hope in healing
Cancer Treatment Centers of America® (CTCA®) takes a unique and integrative approach to cancer care. Our patient-centered care model is founded on a commitment to personalized medicine, tailoring a combination of treatments to the needs of each individual patient. At the same time, we support patients’ quality of life by offering therapies designed to help them manage the side effects of treatment, addressing their physical, spiritual and emotional needs, so they are better able to stay on their treatment regimens and get back to life. At the core of our whole-person approach is what we call the Mother Standard® of care, so named because it requires that we treat our patients, and one another, like we would want our loved ones to be treated. This innovative approach has earned our hospitals a Best Place to Work distinction and numerous accreditations. Each of us has a stake in the successful outcomes of every patient we treat.
Under direct supervision of the Director, Clinical Research and/or Research (Nurse) Manager, the incumbent will coordinate phase I through III oncology research studies and be responsible for maintaining and assuring protocol compliance for all research subjects. The Clinical Research Nurse (CRN) is responsible for regulatory and compliance documentation including protocol training for the clinic staff, imaging department and infusion center, test article accountability, and IRB transactions. The CRN is responsible for establishing relationships with outside providers for required tests not available in-house. The CRN must demonstrate an in-depth knowledge of applicable federal regulations, institutional guidance documents and SOPs for the conduct of clinical trials to ensure human subject protection, compliance with protocol and regulatory requirements and the thorough collection, recording and maintenance of data and source documentation.
The CRN collaborates with Investigators in review of potential protocols and in research subjects’ recruitment and screening for protocol eligibility. The CRN is responsible for developing an individualized strategy for identifying potentially eligible patients for each study. The CRN presents trial concepts and details to the research subjects, participates in the informed consent process, enrolls and coordinates care of subjects in compliance with protocol requirements. The CRN may provide teaching on investigational agents/devices to research subjects and maintains test article accountability. In collaboration with Investigators, the CRN monitors subjects for changes in condition, adverse events, concomitant medication use, protocol compliance, response/reactions to test articles, and thoroughly documents all findings. The CRN is responsible for accurate and timely data collection, documentation, and reporting. The CRN is responsible for entering all patient data in CTMS.
The CRN schedules and/or participates in off-site investigator meetings, pre-site selection visits, site-initiation visits, site-assessments, monitoring visits, and auditing activities as delegated by the Director, Clinical Research and/or Research (Nurse) Manager. The CRN may be responsible for and/or assist with completion and maintenance of regulatory documents in accordance with regulations, hospital and organizational policies and Standard Work Instructions. The CRN will participate in required training and education programs, provide clinical research education to local clinic staff, and ensure site research quality by practicing in compliance with policies, SWIs, principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. The CRN may develop or assist with development of study tools including source documents and eligibility checklists and criteria cards and may be involved in the collection, processing, and shipping of protocol required lab specimens. The CRN maintains adequate supplies to conduct the studies and orders replacements as needed. The CRN maintains the equipment inventory (per protocol) and has appropriate certifications as required by protocol activities e.g., IATA certification. The CRN assists clinicians (LPNs, MAs, and/or RNs) as needed to ensure that protocol-required specimen collections, electrocardiograms, vital signs, study drugs and customary usual care medications, IV start and IV discontinuation as well as follow-up observations are performed per protocol (as applicable).
The Clinical Research Nurse will provide consistent oversight to ensure competent and standardized practices, and coordinate strategies to enhance departmental communication and collaboration.
- Conveys a basic knowledge and understanding of policies, procedures and regulations governing human subject's research and incorporates them in the conduct of research and care of participants.
- Possesses a basic awareness of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations
- With assistance, prepares and processes adverse events according to institutional and departmental policies and procedures and federal regulations
- Possess a basic awareness of the policies and regulations governing the protection of human subjects
- Possesses a basic awareness of the operations of the Institutional Review Board and its requirements of the protection of human subjects
- Communicates a basic knowledge and understanding of the management and implementation of clinical trial operations
- Exhibits the capability to understand and follow a clinical trial protocol
- Understand and is capable of performing the procedures required of each study protocol
- Identifies a procures equipment and supplies needed to fulfill project requirements
- When necessary, records data from source documentation into case report forms with awareness and attention to the requirements for accuracy, completeness and source documentation
- Performs packaging and ships study specimens to the sponsor or laboratory in accordance with IATA and sponsor shipping guidelines
- Participates in onsite or remote visits from Sponsors
- Participates in the determination of eligibility and recruits eligible candidates for study participation
- When necessary, assists with study completion, data lock, study closeout and archiving of study files
- Ensures completeness and continuity of all study data
- Performs ongoing checks of clinical data that has been entered on the case report forms (paper or electronic) to ensure that it is being entered in a timely and accurate manner
- Reviews all study data queries correcting any inaccurate data and flagging questionable data for resolution
- Actively participates in study team meetings
- Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about protections for human participants of research
- With guidance assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials
- Continuously assesses participants to ensure continued eligibility for participation in clinical trials
- Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them while participating in a clinical trial
- Utilizes nursing skills to complete research protocols including patient recruitment, screening, scheduling, and organizing of study lists, enrollment, assessments, interviews, laboratory and diagnostic studies and other protocol specific investigational procedures
- Encourages open communication with participants by providing them with contact information and being available to answer and address their calls
- Uses and documents the nursing process to plan, deliver and evaluate goal focused, individualized, safe, age-specific care as it relates to uncomplicated research participants and with assistance for complicated research participants
- Performs procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine of a protocol amendment or other safety assessments are required
- Schedules subject appointments to utilize time in the clinic efficiently
- Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development
- Pursues avenues to ensure awareness of the latest information available to nurses conducting clinical research
- Demonstrates initiative in self-directed learning, as evidenced by attendance of professional development opportunities.
- Actively seeks new learning opportunities.
- Assumes responsibility for continuous learning, engaging in a minimum of 5 hours of educational activities annually or pursuing an advanced academic education or certifications
- Participates in and maintains professional certifications, licensure and credentialing as required of clinic nursing staff
- Further knowledge base by attending the Basic Research 101 within first three months of employment date
- Further knowledge base by attending the Caring for the Oncology Basics course within first three months of employment date
- Preserve the integrity of clinical research data:
- Document and report adverse and unanticipated events to the investigator, regulatory specialist, sponsor, and the IRB as appropriate
- Ensure data collection and data entry into CRFs.
- Performs timely and accurate data edits and query resolution
Skills, Education and Additional Information
- Minimum 2 years clinical research experience
- Associate Degree in Nursing or equivalent
- Valid RN license in Arizona
- Basic life Support (BLS) within 1 month of employment
- Human Subjects Protection (HSP) within 1 month of employment
- Good Clinical Practice (GCP) within 1 month of employment
- International Air Transport Association (IATA) within 1 month of employment
- Certification through SoCRA, ACRP, or other reputable entity within 4 years
- Basic oncology class within 6 months of employment
Each CTCA employee is a Stakeholder, driven to make a true difference and help win the fight against cancer. Each day is a challenge, but this unique experience comes with rewards that you may never have thought possible. To ensure each team member brings his or her best self, we offer exceptional support and immersive training to encourage your personal and professional growth. If you’re ready to be part of something bigger and work with a passionate, dynamic group of care professionals, we invite you to join us. Visit: Jobs.cancercenter.com to begin your journey.
We win together
Each CTCA employee is a Stakeholder, driven to make a true difference and help win the fight against cancer. Each day is a challenge, but this unique experience comes with rewards that you may never have thought possible. To ensure each team member brings his or her best self, we offer exceptional support and immersive training to encourage your personal and professional growth. If you’re ready to be part of something bigger and work with a passionate, dynamic group of care professionals, we invite you to join us.
Visit: Jobs.cancercenter.com to begin your journey.