Job Description: Oregon Health & Science University
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 aaeo@ohsu.edu.
Clinical Research Coordinator
US-OR-Portland
Job ID: 2024-32404 Type: Regular Full-Time # of Openings: 1 Category: Research Portland, OR (Waterfront)
Overview
The Knight Cancer Institute Clinical Research Assistant 2 is responsible for assisting with various duties to facilitate oncology clinical research.
The CRA2 will collaborate with the study team to:
Assemble initial patient charts;
Courier and coordinate study related medications from pharmacy to the patient during their visit;
Facilitate completion of quality of life questionnaires with patient during their visit;
Perform electrocardiogram on patients during their visit;
Assist with patient data entry into a database or web based applications
Collect data for case report forms and queries
Abstract basic data from medical records, process/ship specimens, contact of patients for survival info;
Order medical records for clinical trial reporting
Assist in the maintenance of regulatory documents and obtain signatures.
Depending on experience, this position may also coordinate non-treatment-related oncology studies and/or oncology-treatment-related studies that have patients in active or long-term follow up with oversight by Clinical Research Manager or senior study coordinators. This position will assist the Clinical Research Manager with other projects as needed.
The CRA2 will be expected to obtain and maintain a working knowledge of National Cancer Institute (NCI), FDA, DHHS and other agency guidelines that govern oncology clinical research. Additionally, the CRC is required to learn the basics about the oncology diseases that their team manages and know how to apply this knowledge to the tasks they manage. The CRA2 is also required to have a basic understanding of the study financial lifecycle and how their work directly impacts this.
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, and above average critical judgment skills are essential. Requires supervision; able to complete responsibilities with oversight; performs routine clinical research tasks (e.g., tissue sample management, medical record acquisition, specimen processing); some innovation and problem solving.
Under general supervision, assists in coordinating the details of therapeutic interventional research studies and protocol documentations, patient scheduling, and data collection. Assists in complex studies.
Key Responsonsilbilites:
Responsible for assisting the study team with critical aspects of oncology clinical trial management from startup to closeout. Responsible for ensuring appropriate conduct of protocols to NCI and FDA guidelines. This includes, but is not limited to:
Regulatory Maintenance and creation of necessary sponsor, Knight, OHSU and departmental clinical trial documents and tools that facilitate study efficiency and team communication
Locating and ordering medical records from referring providers to facilitate research patient care and data entry for the study team.
Review medical records to abstract pertinent information for basic data entry. May participate in simple database creation and maintenance. Enter data into web based applications, eCRIS, EPIC, paper data collection forms and other OHSU systems as needed. Centralizing entry of research association EPIC and required patient data into a CTMS system
Resolve queries from sponsors to clarify medical data collected from current and past clinical trials
Collect patient source documents including progress notes, lab reports, CT reports, and pathology reports from OHSU and other medical institutions. Obtain patient x-rays, CT scans, MRIs or other appropriate films. Assisting in obtaining outside slide or pathology samples as needed.
May also co-coordinate long term treatment trials with Manager or senior study coordinator oversight
Responsible for ordering study supplies and maintaining an up to date inventory for each study.
Invoice submission for tasks related to their role
Assist study team with patient visits, including but not limited to:
Coordination study drug ordering and delivery from pharmacy to patient/study team.
Assist study coordinators in assessing sample collection requirements and assembling study kits.
Basic and complex sample management: collection, processing and shipping
May have direct patient contact to obtain or verify information and working with study team to triage clinical information and patient questions. May work with the study team and clinic to conduct timely blood draws (PKs), ECGs, vitals (blood pressure, temp, respirations, height, weight), wearable data tracking device management or other study-related procedures. Procure and process human biological specimens (including but not limited to blood, urine, feces, sputum, tissue). May facilitate patient’s completing and Patient Reported Outcome (PRO) questionnaires via paper forms, electronic tablets or verbal discussion and recording.
Assist in the consenting process for observational studies and/or the pre-screening portion of an interventional trial.
Provide follow up for subjects who are no longer receiving
Responsibilities
Education & experience:
Bachelor's in relevant field and no experience OR
Associate's AND 2 years of relevant experience OR
3 years of relevant experience OR
Equivalent combination of training and experience.
Knowledge, skills, and abilities:
Ability to prioritize 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, Word and PowerPoint
Excellent customer service skills
Ability to work with a variety of diverse individuals and personalities
Energy and drive to coordinate multiple projects simultaneously
Ability to use tact and diplomacy to maintain effective working relationships
Qualifications
Education & experience:
Bachelor's degree with coursework in Science
At least one year of general office experience
Clinical research experience
Research experience with some knowledge of clinical trials
Experience coordinating different phases of projects, including data collection
Customer service experience
Knowledge, skills, and abilities:
Microsoft Office, Access, and/or other networking and database systems
