Overview
It may sound cliche, but it is true. A career taking care of cancer patients is a calling for most all of us. It's much more than a job. Each of us has a unique story that brought us to Compass Oncology, but those stories usually share common themes of care, compassion, and commitment. No matter the role, each Compass team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. If this sounds like you, please reach out to us. We can't wait to hear your story.
If you are a dedicated, team-oriented, patient-centered individual looking for an opportunity where you are proud of what you do, work hard, have fun, and go home at the end of the day knowing you made a difference in the lives of our patients; Compass Oncology is the place for you.
Employment Type: Full-Time (40 hours), M-F
Location: This role will sit at our Central Business Office located in Vancouver, WA.
Salary Range: $25.34- $38.61
Final offer amounts are determined by multiple factors including candidate experience and expertise as well as internal employee equity considerations.
Scope: Under general supervision, the Regulatory Affairs Coordinator is responsible for supporting the regulatory team with coordinating the research regulatory and administrative activities of clinical trials for the practice. Coordinates the preparation of regulatory submissions for new and continuing review of clinical trials. Works closely with US Oncology Regulatory and Sponsors in coordination of study start-up and closure procedures. Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
Responsibilities
Key Responsibilities
Coordinates Critical Document Collection to facilitate the timely opening of trials at the site.
Maintains Protocol Regulatory Documents in compliance with local and US Oncology Standard Operating Procedures. Reviews Investigator files and verifies all regulatory documents are filed in accordance with federal, state, and local regulations.
Assists with scheduling for monitoring visits, study start up visits, close out visits, and audits as needed. Communicates issues with regulatory documents or procedures to clinical staff, research management, and investigators.
Assists with preparation of Informed Consent Documents and creates regulatory packets (FDA1572, FDQ) for sponsor and IRB submissions. Coordinates local and central Institutional Review Board submissions.
Facilitates collection of site training documents from study initiation visits as well as coordinates and collects ongoing amendment training documents.
May compile information necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for USOR trials.
Coordinates the completion of feasibility surveys with appropriate staff including PI, research management and others as needed.
Qualifications
Minimum Job Qualifications (Knowledge, Skills, & Abilities):
Education/Training -
High school diploma or equivalent required; some college coursework or other relevant background preferred
Minimum one year of experience in a clinical research regulatory affairs and/or an oncology related field required
Business Experience -
Experience in Microsoft Office
Experience working with Sponsor Monitor representatives
Specialized Knowledge/Skills -
Experience working in clinical research is preferred
Must have excellent communication skills
Strong ability to multi-task
Excellent time management skills
Must have strong interpe
