Specialist, Clinical Research
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
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 CRC 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 CRC is responsible for establishing relationships with outside providers for required tests not available in-house. The CRC 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 CRC collaborates with physicians/investigators in review of potential protocols and in research subjects’ recruitment and screening for protocol eligibility. The CRC is responsible for developing an individualized strategy for identifying potentially eligible patients for each study. The CRC 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 CRC may provide teaching on investigational agents/devices to research subjects and maintains test article accountability. In collaboration with physicians/investigators, the CRC monitors subjects for changes in condition, adverse events, concomitant medication use, protocol compliance, response/reactions to test articles, and thoroughly documents all findings. The CRC is responsible for accurate and timely data collection, documentation, and reporting. The CRC is responsible for entering all patient data in CTMS. This CRC is responsible for identifying research charges on patient bills. The CRC 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 Research (Nurse) Manager and/or Director, Clinical Research. The CRC 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 CRC 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 CRC 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 CRC maintains adequate supplies to conduct the studies and orders replacements as needed. The CRC maintains the equipment inventory (per protocol) and has appropriate certifications as required by protocol activities e.g., IATA certification). The CRC 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 CRC may work in collaboration with Regulatory Coordinators, Data Coordinators, and Clinical Research Nurses as scope of work and project demands dictate.
- Bachelor's degree in a healthcare or business related field with healthcare experience (Business Administration, Health Care Administration, clinical field (science, health, medicine, pharmacy, nursing), OR equivalent experience
- minimum of 2 years of hospital experience
- Certification through SoCRA, ACRP, or other reputable entity within 3 years
- Basic Life Support training within 6 months
- Human Subjects Protection training/certification within 90 days
- Availability for off hours coverage and occasional travel
- Basic Oncology class within 1 year of employment.
Level 1 Preferred:
- 3+ years of research experience
- 3+ years of clinical oncology experience
- Master’s degree in a healthcare or business related field with healthcare experience (Business Administration, Health Care Administration, clinical field (science, health, medicine, pharmacy, nursing)
- Certification through Society of Clinical Research Associates, Association of Clinical Research Professionals, or other reputable entity
- Phase I clinical research experience
- Lifting of up to 10lbs
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
Visit: Jobs.cancercenter.com to begin your journey.