TI Sr. Clinical Research Assistant (Clinical Research Coordinator)

Oregon Health & Science University•Portland, OR

About The Position

Department Overview 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 requires management of complex therapeutic interventional (TI) trials and clinical research studies involving a very vulnerable and sick population. Therapeutic Interventional (TI) trials are treatment studies that involve people who have a disease or underlying condition. They include the administration and testing new treatments or new ways of using existing treatments, such as new drugs, vaccines, or Cell Therapies. Function/Duties of Position This Therapeutic Interventional (TI) Clinical Research Assistant is responsible for the overall management of clinical trials on the Acute Leukemia and MDS/MPN team. This may include: Working with the regulatory management team to complete all regulatory documentation in accordance with their role as required by the OHSU IRB and sponsor Creation of study trackers and organization tools Assisting in the verification of patient eligibility Development of data collection instruments and assistance with regulatory Data entry Assurance of conduct of protocol in accordance with applicable NCI and FDA guidelines Maintenance of study patient records and source documentation Coordinating orders, scheduling and study drug administration with the clinical team Supporting clinical care team with completion of research required tests and assessments Act as liaison between research protocol and clinic staff, pharmacy, and research participants Ensuring that patient billing is accurate and assisting manager and financial team in verifying appropriate clinical trial billing. Participation in patient consenting Support and periodic coverage to and across study teams, as delegated by the Clinical Research Manager. This includes, but is not limited to: assisting with maintaining regulatory documents, patient visits and study assessments (e.g., ECGs, vitals, specimen collection, management and shipping, etc.), requesting medical records, and other study related tasks, as needed. This TI Clinical Research Assistant will have direct patient contact, process biological samples, and may perform other non-invasive testing such as ECGs. The TI Clinical Research Assistant will also assist in the continuing education of physicians, residents, interns, nurses and other related personnel with regards to knowledge of clinical trials and activities.

Requirements

Bachelor's Degree in relevant field and 1 year of relevant experience OR Associate's and 3 years of relevant experience OR No degree and 4 years of relevant experience OR Equivalent combination of training and experience.
High degree of attention to detail
Ability to prioritize and complete multiple tasks at one time
Excellent communication, analytical and organizational skills: both written and verbal
Ability to work independently and as part of a team while being collaborative in resolving problems
Proficiency with computers running Windows and PC applications (e.g. MS Excel, Oracle, Access, Word and PowerPoint)
Demonstrated excellent customer service skills both on the phone and in person
Possess energy and drive to coordinate multiple projects simultaneously
Ability to use tact and diplomacy to maintain effective working relationships
Critical Thinking skills
Time management skills

Nice To Haves

Clinical trial knowledge with a minimum of 1 year of research experience
Experience conducting different phases of projects, including data collection and 3-5 years of clinical trial experience
Networking and database systems
Medical terminology
Working knowledge of Epic
CCRP or ACRP Certification
Typing 40+ wpm

Responsibilities

Working with the regulatory management team to complete all regulatory documentation in accordance with their role as required by the OHSU IRB and sponsor
Creation of study trackers and organization tools
Assisting in the verification of patient eligibility
Development of data collection instruments and assistance with regulatory Data entry
Assurance of conduct of protocol in accordance with applicable NCI and FDA guidelines
Maintenance of study patient records and source documentation
Coordinating orders, scheduling and study drug administration with the clinical team
Supporting clinical care team with completion of research required tests and assessments
Act as liaison between research protocol and clinic staff, pharmacy, and research participants
Ensuring that patient billing is accurate and assisting manager and financial team in verifying appropriate clinical trial billing.
Participation in patient consenting
Support and periodic coverage to and across study teams, as delegated by the Clinical Research Manager. This includes, but is not limited to: assisting with maintaining regulatory documents, patient visits and study assessments (e.g., ECGs, vitals, specimen collection, management and shipping, etc.), requesting medical records, and other study related tasks, as needed.
Assist in the continuing education of physicians, residents, interns, nurses and other related personnel with regards to knowledge of clinical trials and activities.