The mission of the Knight Clinical Research Management organization is to support the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention, screening diagnosis and treatment. The support is provided through proactive, high quality and efficient study management in compliance with federal regulations and local policies and procedures. This fast-paced and highly intense research environment require management of complex clinical research studies involving a very vulnerable and sick population.
This Senior Clinical Research Coordinator position will be part of the Knight Clinical Research Lymphoma Team . This position will involve coordinating complex phase 1-3 trials on an oncology research team with a very active Investigator Initiated Trial portfolio. They would be deeply involved in study feasibility reviews, study tool building, and team education and training.
Longer term, they will also be working on both the Early Phase Unit (when it opens), the clinic and infusion unit, and will help develop workflows for the inpatient unit.
If you do not meet the minimum qualifications for this Senior level Clinical Research Coordinator (CRC) position, consider applying for one of our Novice or Practitioner level CRC positions, which can be found in the "Additional Details" section below.
These responsibilities include assisting with components of the IRB submission, to include preparation of consent forms and other documents required for IRB review. On-study duties include the coordination of all aspects of a study as specifically outlined in the protocol. Primary focus will be subject safety and compliance with the prescribed protocol and Good Clinical Practice. The Sr. CRC will work collaboratively with physician, nursing, and ancillary staff in the scheduling and management of subject research activities. The Sr. CRC will maintain accurate, complete and timely records on all research subjects including preparation of source documentation and clinical research data/case report forms. The Sr. CRC will ensure that patient billing is accurate and assist the manager and financial team in verifying appropriate clinical trial billing for very complex oncology trials. This requires the Sr. CRC to have a strong understanding of the study financial lifecycle and how their work directly impacts this. The Sr. CRC may have direct patient contact, process biological samples and may perform other non-invasive testing, such as ECGs.
The Sr. CRC will represent the investigator and institution during monitor visits and on-site audits conducted by the sponsor or sponsor representative. The Sr. CRC will have and maintain a working knowledge of National Cancer Institute (NCI), FDA, DHHS and other agency guidelines that govern clinical research. Additionally, the Sr. CRC is required to learn and remain up to date on the oncology disease sites their team manages. This includes understanding the basic disease processes and current standard of care therapies used for each disease site. The Sr. CRC must be able to apply this knowledge to the tasks they are assigned.
Given the complexities of oncology research and the challenges of working with a terminally ill population, strong customer service, organizational, and interpersonal skills are required. Ability to clearly organize and/or adapt to multiple priorities and deadlines at one time is necessary. Attention to detail, service orientation, delegation and project management skills, and above average critical judgment skills are essential.
Requires limited supervision; limited assistance required; Clinical Research Coordinator-Practitioner responsibilities, plus very strong understanding of research regulations and best practices; strong data abstraction skills and strong project management skills; provides assistance and training to junior staff. With increased responsibilities, typical ownership of increased oncology trial and patient population complexity.
Bachelors Degree and at least 3 years of relevant experience.
Strong understanding of research regulations and best practices
Strong data abstraction skills
Strong project management skills
Ability to prioritize multiple tasks at one time
Excellent communication, both written and verbal
Strong analytical and organizational skills
Ability to work independently and as part of a team while being collaborative in resolving problems
Proficiency with computers running Windows, PC applications, and the Microsoft Office suite, e.g., MS Excel, Outlook, Access, Word, and PowerPoint
Excellent customer service skills both on the phone and in person
Energy and drive to coordinate multiple projects simultaneously
Ability to use tact and diplomacy to maintain effective working relationships
Every Knight Cancer employee is expected to embody our guiding principles:
We act BOLDLYBreakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently.
We SUPPORT each otherRespect leads to trust, which leads to excellence.
We work as a CONNECTED team We must leverage our collective brain power to conquer cancer because no one individual can do it alone.
CCRP or ACRP Certification
Direct clinical research experience
Experience conducting different phases of projects, including data collection
Experience with networking and database systems
Familiarity with medical terminology
Working knowledge of Epic
If you do not meet the minimum qualifications for this Senior level Clinical Research Coordinator (CRC) position, consider applying for one of our Novice or Practitioner level CRC positions here:
Note to internal OHSU applicants: to apply to the above-mentioned posting, you must access it from the internal OHSU job portal and search byReq# 2019-1596.
Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or firstname.lastname@example.org.
As the state's only health and research university, OHSU brings together patient care, research, education of the next generation of health care providers and scientists and community service to improve the health and well-being of all Oregonians.The university is a conduit for learning for more than 2,800 students, providing training to interns, residents and fellows in postgraduate medical and research. It is the only place in Oregon that grants doctoral degrees in medicine, dentistry and nursing. OHSU cares for more than 251,000 patients each year from around the region and takes a leadership role in contributing to solutions involving the health of the state and the nation, such as health care access and transparency, ethics and workforce shortage. Beyond providing critical health care services, quality education and cutting-edge research, OHSU also is a key economic and social force in the Northwest. With an annual operating budget of $2.06 billion and more than 14,000 employees, OHSU is Portland?s largest employer. Its size contributes to its ability to provide... many services and community support activities not found anywhere else in Oregon. For more information visit http://www.ohsu.edu/xd/about/index.cfm