Clinical Research Coordinator
Cancer care is all we do
Hope in healing
Cancer Treatment Centers of America® (CTCA), part of City of Hope, 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.
Hours: Mon - Fri, 7:30am - 4:00pm
Under direct supervision of the Clinical Research 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 Coordinator (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 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 Investigators in review of potential protocols and in research subjects’ recruitment and pre-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. In collaboration with 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.
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 Manager. 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 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 biospecimen 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 and within the scope of technical expertise and license status).
The CRC seeks supervision appropriately, prioritizes appropriately, completes work in a timely manner and demonstrates accuracy in all details.
Bachelor's Degree in Health Science or related field from an accredited university,
Master's degree in a healthcare or clinical field (science, health, medicine, pharmacy), OR equivalent experience - Preferred
Minimum of 2 years of research experience
Certification through SoCRA, ACRP, or other reputable entity within 3 years of employment
Human Subjects Protection training/certification within 30 days of employment
Basic Oncology class within 1 year of employment (if necessary)
3+ years of experience working with clinical trials (preference will be given to candidates with the pharmaceutical industry experience and academia)
3+ years of clinical oncology experience
Certification through Society of Clinical Research Associates, Association of Clinical Research Professionals, or other reputable entity
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.